Check nominal layer fit, prepare your RFQ, then compare the evidence a development and manufacturing partner should provide.
Prepared by Catheter Braiding OEM (Catheter Braiding OEM). First recorded in this site’s repository October 25, 2026; public release date is unverified. Engineering interpretation reviewed . These recommendations combine the explicit geometry below with public source scopes; they are not supplier audit findings.
If liner and crossover envelope consume the radial wall, change the dimensions before requesting a build. A positive remainder still needs tolerance review. See the reproducible method.
Flat versus round wire is a prototype comparison, not proof of equivalent torque or kink resistance. Define conditions and criteria before testing. [S2]
Ask for controlled records, test reports and quality responsibilities at each transfer gate. Supplier certification remains unconfirmed until records are reviewed. [S3]
The tool uses an ideal circular, single-lumen shaft with one liner and a two-wire crossover. Calculations retain full numerical precision internally; exported decimals are rounded for readability. Input ranges limit this tool, and do not describe manufacturing capability.
| Quantity | Method | Limitation |
|---|---|---|
| OD in mm | OD (Fr) ÷ 3 | Use finished-part OD, not an introducer compatibility label. |
| OD in inches | OD (mm) ÷ 25.4 | 1 inch = 25.4 mm. |
| Total radial wall | (OD in inches − ID in inches) ÷ 2 | ID must be strictly smaller than OD. |
| Braid radial envelope | 2 × wire thickness (or round-wire diameter) | Simplified crossover assumption; no compression credit. |
| Remaining jacket space | Radial wall − liner wall − braid envelope | Must be positive; excludes tolerances and extra features. |
| Screening flags | Jacket < 0.0008 in; flat-wire aspect ratio > 4.5:1 | Illustrative internal review flags, not validated acceptance limits. |
Known: entered nominal dimensions and the arithmetic above. Unknown: braid angle/coverage, final bond quality, process yield and mechanical performance. PPI and carrier count are RFQ context; the supplier must confirm pick convention and actual braid geometry.
Use these as engineering comparison questions. No universal percentage improvement, equivalent stiffness or material safety claim is established by this page. Require representative bench evidence for the final assembly. [S2]
| Option | Question to resolve | Tradeoff / next evidence |
|---|---|---|
| Flat wire | Does specified thickness leave more nominal jacket space? | Width, rollover and orientation need supplier cross-section review. |
| Round wire | Can the diameter fit while meeting the same device targets? | Compare coupon handling, composite behavior and quoted cost; do not infer equivalence. |
| Nitinol / stainless / tungsten / PEEK | What grade, finish and behavior does the application require? | Obtain material certificates and assembly-specific test evidence; no MR status inferred. |
| Coil or braid/coil hybrid | Does the distal function need a different reinforcement approach? | Budget transition overlap and test the joint; compare a separate concept, not an assumed drop-in replacement. |
Positive nominal clearance is only the first screen. Ask for a supplier-reviewed tolerance stack before setting drawing acceptance limits. A conservative starting expression is (minimum OD − maximum ID) ÷ 2 − maximum liner − 2 × maximum wire thickness; additional features require their own envelope.
| Variable | Risk if ignored | Evidence to request |
|---|---|---|
| OD and ID tolerances | Nominal clearance can disappear at the dimensional extremes. | Worst-case stack, metrology method and measurement capability. |
| Wire crossover / embedding | Actual braid height may differ from the ideal envelope. | Sections from representative reflow coupons; document orientation and sampling. |
| Markers, pull wires, adhesive, coating | Local wall consumption or stiffness changes are absent from this tool. | Feature-specific sections, dimension budget and transition tests. |
| Concentricity and process variation | One side of the wall can be thinner than the nominal budget. | Section locations, measurement uncertainty, lot data and agreed criteria. |
The practical recommendation is to review records that apply to the proposed site, process and part. The FDA QMSR framework is relevant context; it is not a certificate for this website or a guarantee about any factory. [S3]
| Decision | Ask for | What remains unproven |
|---|---|---|
| Quality system scope | Current certificate, issuing body, scope, site and applicable quality agreement. | A certificate alone does not establish shaft-specific process capability. |
| Braid / reflow capability | Representative coupons and dimensional data using the intended stack. | A machine list does not prove yield or performance. |
| Environment and traceability | Relevant environmental records, material traceability and release records. | No cleanroom classification is claimed on this page. |
| Measurement / process control | Measurement study, sampling rationale and relevant lot data. | Do not treat one generic Cpk value as a universal release rule. |
| Ownership and continuity | Tooling ownership, recipe access, change notification and transfer terms. | NDA terms alone do not settle background IP or transfer rights. |
ISO 10555-1 provides catheter requirements within its scope; the sponsor should determine applicable editions, clauses and device-specific additions. FDA bench-report guidance supports documented protocols and reports, not predetermined passing values. [S1] [S2]
| Concern | Protocol inputs to agree | Result needed for a decision |
|---|---|---|
| Tensile joints / shaft | Sample configuration, conditioning, pull setup and acceptance criteria. | Failure load, location, mode and rationale against the requirement. |
| Pressure / aspiration collapse | Pressure medium, loading, duration, temperature and assembly state. | Measured leakage or collapse behavior; no predicted psi rating from this tool. |
| Kink / tracking / torque | Anatomical path or fixture, bend conditions, rotation and endpoints. | Repeatable response including lag, recovery and failure observations. |
| Sterilization / aging | Exact assembly, process exposure, packaging, aging and retest plan. | Validated compatibility and residuals where applicable; no universal material guarantee. |
| MR evaluation | All assembly components, intended conditions and appropriate assessment plan. | Device-specific evaluation and labeling; material name is insufficient. |
Do not substitute ASTM F2606 stent bending for a catheter kink protocol or ASTM D2578 film wetting for PTFE bond qualification without a justified adaptation. [S4] [S5]
| Stage | Decision before advancing | Schedule and cost dependencies |
|---|---|---|
| Prototype / DFM | Do measured sections and dimensions justify the next design revision? | Material availability, mandrel design, tooling and coupon iterations. |
| Design verification | Does the representative design meet approved requirements? | Protocol agreement, sample count, fixtures and failure resolution. |
| Pilot qualification | Is the process evidence adequate for the agreed production scope? | Representative lots, measurement capability, controls and documentation. |
| Commercial transfer | Are ownership, quality and release responsibilities accepted? | Transfer package, supply agreement, capacity and applicable packaging/sterilization work. |
Prices, MOQ and delivery dates: not verified. Request written line items for NRE/tooling, samples, inspection, destructive tests, qualification, packaging and recurring units. Compare quotations using the same drawing revision and included services.
| Risk | Consequence | Mitigation / alternative |
|---|---|---|
| Treating nominal fit as approval | Functional or local wall failures can be missed. | Review tolerances and assembly tests before approving a drawing. |
| Overfitting early tooling | Scrap and repeat NRE if the design changes. | Agree a coupon phase and ownership terms before production tooling. |
| Mismatched scope | A braid-only supplier may not cover assembly validation or documentation. | Map responsibilities; use a qualified assembly partner or separate the scope explicitly. |
| Unbudgeted qualification | Low unit quotes hide testing and transfer work. | Compare lifecycle line items and acceptance deliverables. |
| Wrong model for the shaft | Multi-lumen, tapered, steerable or hybrid features invalidate the simple wall budget. | Use local cross-sections and a feature-specific drawing review instead of this calculator alone. |
These are hypothetical calculations, not customer cases or measured results. No pressure, fatigue or clinical outcome is claimed. The same assumptions are used as in the tool.
| Concept / inputs | Calculation result | Next decision |
|---|---|---|
| 1.9 Fr, ID 0.017; liner 0.0005; wire 0.0005 | OD 0.6333 mm; radial wall 0.003967 in; jacket space 0.002467 in. | Positive nominal budget. Check tolerance extremes, sections and device-specific testing. |
| 6 Fr, ID 0.071; liner 0.0008; wire 0.0009 | OD 2.0000 mm; radial wall 0.003870 in; jacket space 0.001270 in. | Compare local markers and worst-case tolerances before relying on the thin-wall concept. |
| 12 Fr, ID 0.145; liner 0.0015; wire 0.0020 | OD 4.0000 mm; radial wall 0.006240 in; jacket space 0.000740 in. | Small-allowance flag triggers. Review thinner layers or larger OD with the supplier; it is not a universal rejection limit. |
Boundary example: 14 Fr OD is about 4.667 mm, so an ID of 0.185 in (4.699 mm) cannot fit. The tool rejects ID ≥ OD and prevents export until inputs are corrected.
Public source scopes checked October 25, 2026. FDA bench-report guidance is dated December 2019; FDA states QMSR took effect February 2, 2026. Catalogue descriptions are used for scope checking, not as a substitute for full licensed standards or regulatory review.
Catalogue scope: general requirements for sterile, single-use intravascular catheters.
Boundary: Public scope does not establish a universal jacket minimum or prove this shaft meets the standard. Use the full applicable standard for a test plan.
Explains documentation for bench protocols, summaries and reports in premarket submissions.
Boundary: Device-specific testing is required. This is not a source for fixed torque, kink or burst criteria, and it excludes computational modeling and sterilization validation.
FDA states that QMSR became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference.
Boundary: This framework does not prove any supplier is certified or that a specific process is qualified. Confirm applicability with the device sponsor.
The catalogue identifies three-point bending of balloon-expandable vascular stents and stent systems.
Boundary: It is not a catheter-shaft kink test. Any adapted method needs a documented rationale, fixture, conditioning and acceptance criteria.
The catalogue identifies wetting tension testing for polyethylene and polypropylene films.
Boundary: It does not directly set etched-PTFE adhesion acceptance. Agree a substrate-specific surface and bond verification method with the supplier.
Evidence not provided: supplier certificates, cleanroom records, production capability data, performance test reports and quotations. No ratings or price forecasts are inferred from those unknowns.
It converts Fr to nominal OD and subtracts liner plus a two-wire crossover envelope from the radial wall budget. It prepares an RFQ brief. It does not predict functional performance or select a qualified CDMO.
No. It only means the simplified nominal dimensions fit. Tolerances, wire orientation, reflow movement, additional features and process evidence can change the outcome. Request worst-case stack and cross-section review.
It is an illustrative internal screening threshold to prioritize discussion, not a published universal limit or a manufacturing acceptance criterion. The CDMO must justify an appropriate allowance for the actual materials and process.
Reset to an illustrative example to explore the method. For a real project, use Request DFM review and attach the drawing. If clipboard access fails, open the manual brief and select its text to copy.
Compare both when lumen and wall constraints are important. Flat-wire thickness and width are independent inputs; round wire uses its diameter. Match physical samples against the same requirements before assuming equal stiffness, durability or cost.
PPI conventions, number of ends, pattern and braid pitch diameter must be agreed with the supplier. An unverified angle or coverage formula would give false precision. Ask for optical braid measurements on representative coupons.
No MR status is inferred here. Material selection alone cannot establish the behavior of the finished assembly, including markers, joints and other metal parts. Request assembly-specific evidence and labeling review.
No. PPI is recorded as a requested process setting. Mechanical response also depends on wire, pattern, bond state, polymer, length and loading conditions; compare prototypes under an agreed protocol.
Request separate development/tooling, material, build, metrology, destructive-test and qualification costs. Specify drawing revision, quantity, acceptance criteria and required documentation so quotes can be compared on the same scope.
They are not verified on this page. Ask the supplier to confirm stock, tooling, build quantity, testing capacity, release criteria and schedule dependencies in a written quotation.
No supplier certificate or facility report is presented. Request current certificate scope, site details, relevant controlled-environment records and process qualification evidence before making a sourcing decision.
Define ownership, access, maintenance and transfer rights in the development and quality agreements. An NDA alone does not establish ownership of tooling, recipes or background intellectual property.
The public catalogue describes general requirements for sterile, single-use intravascular catheters. It does not establish the nominal wall assumptions in this tool. Review the full applicable standard and intended use with the device sponsor.
Its catalogue scope is stent and stent-system three-point bending. Do not present it as a catheter-shaft kink standard. Agree and justify a device-specific kink method, especially if adapting another method.
No. Review representative lots, measurement capability, process controls, yield, traceability and changes before release. Agree capability targets from product risk and data; a single generic Cpk threshold is not proof of readiness.
This page cannot determine that. The device sponsor must assess the specific design, process, supplier and market changes, document the evaluation and obtain appropriate regulatory review before implementation.
Copy the tool brief and attach a controlled drawing. Include OD/ID tolerances, local features, length and zones, material preferences, intended use, test targets, quantity, development stage and requested documentation. Request confirmation of scope, open risks, NRE, unit price and schedule dependencies.
Email the RFQ checklistIf email is unavailable, use the tool’s selectable brief and your existing procurement channel. Agree confidentiality and transfer terms before sending proprietary drawings.