ISO 13485 Supplier Readiness
We support buyer-side supplier qualification with traceability, inspection records, and document controls aligned to ISO 13485 expectations. Certification evidence should be confirmed during supplier audit.
Company Profile
Catheter Braiding OEM Team
Catheter Braiding OEM supports global medical device teams with reinforced catheter shaft sourcing, prototype review, and export-focused OEM coordination.
We focus on reinforced catheter shaft components, including braided catheter shafts, coil reinforced catheters, PTFE lined shafts, marker band assemblies, and catheter reflow process support for OEM and CDMO buyers.
Backed by Linkup Ai Co., Ltd. Manufacturing delivered by the Advanced Manufacturing Division of Linkup Precision. Legal entity: Linkup Ai Co., Ltd.
Controlled Process Areas
Critical extrusion, braiding, coil winding, and reflow lamination steps are planned with controlled environment, material handling, cleaning, and inspection requirements matched to the buyer's quality plan.
Engineering Collaboration
Early DFM support for OD/ID stack-up, braid density (PIC), coil pitch, transition zones, marker placement, and process validation (IQ/OQ/PQ) checkpoints.
Manufacturing Sites & Infrastructure
Our production capabilities are coordinated through advanced manufacturing resources in Shenzhen and Dongguan, China, with precision tooling, controlled process areas, and quality inspection workflows for medical device OEM component programs.
Precision CNC Workshop
High-accuracy machining centers dedicated to specialized tooling, mandrels, and custom catheter components.
Controlled Process Areas
Process-controlled areas for critical extrusion, precision braiding, coil winding, and reflow lamination steps according to the buyer's quality plan.
Quality Inspection Laboratory
Strict dimensional and performance testing under microscopes and advanced measurement systems to ensure CTQ compliance.
Capability Matrix for Catheter Buyers
| Capability Area | What We Support | Buyer Value |
|---|---|---|
| Shaft Architecture | Braided, coil reinforced, hybrid braid-and-coil, PTFE lined, Pebax or nylon jacketed, and multi-zone shaft designs | Lets engineering teams compare pushability, torque response, kink resistance, and distal flexibility tradeoffs. |
| Reinforcement Inputs | Stainless, nitinol, tungsten, flat wire, round wire, braid angle, PIC count, coil pitch, and variable-zone structures | Converts early clinical-handling targets into manufacturable reinforcement specifications. |
| Assembly Integration | Marker bands, radiopaque elements, tip transitions, mandrel-based lamination, reflow, and subassembly support | Reduces supplier handoff risk across tubing, reinforcement, lamination, and inspection steps. |
| Quality & Delivery | Incoming material checks, dimensional inspection, documentation packages, pilot run controls, and export execution planning | Improves sample gate traceability and repeat-order predictability for regulated-device programs. |
Commercial Scope
- RFQ support for catheter R&D teams, OEMs, CDMOs, and sourcing groups
- Prototype, pilot, validation-support, and recurring production programs
- Collaboration on drawings, shaft stack requirements, trade terms, and delivery plans
Trust and Documentation
- Technical communication via [email protected]
- Traceable quote and revision workflow for engineering changes
- Inspection, material, and compliance file support by project scope
Factory Collaboration Workflow
- Requirement alignment: freeze OD, ID, length, liner, jacket, reinforcement method, target shaft zones, and validation scope.
- Prototype governance: define CTQ checkpoints, pass/fail thresholds, drawing revision ownership, and sample labeling rules.
- Pilot readiness: map control plan, outgoing records, packaging, and delivery rhythm to buyer-side verification cadence.
Next Pages for Qualification Teams
- Products for braided shaft, coil reinforced shaft, PTFE lined shaft, and marker assembly comparison.
- Solutions / Applications for neurovascular, structural heart, endovascular access, and steerable shaft use cases.
- OEM Capabilities for braiding, coil winding, reflow lamination, shaft assembly, and quality execution controls.
- Engineering Blog for practical catheter shaft sourcing checklists and decision guides.
- Balloon CDMO Guide for evaluating manufacturing capabilities for balloon catheters.
- Contact / RFQ when your team is ready for technical-commercial alignment.
Inquiry Email
Include OD/ID, shaft stack, prototype quantity, and delivery location.