Catheters & Cannulas
Platinum-cured LSR tubing, cuffs and tips produced in a class-100,000 cleanroom with full lot traceability.
Application Overview
Catheters and cannulas demand a material that is biocompatible, kink-resistant and gentle on tissue. We extrude and mold medical-grade LSR tubing with tight ID/OD control and smooth, flashless surfaces to minimize tissue trauma. Options include radiopaque-filled grades, pigmented compounds and bonded multi-durometer assemblies. Every production lot is manufactured and packaged inside our ISO 13485-aligned cleanroom.
Technical Standards
- ✓ISO 10993-1 / -5 / -10 biocompatibility (cytotoxicity, sensitization, irritation) test reports available per lot
- ✓USP Class VI and FDA 21 CFR 177.2600 compliant material grades
- ✓ISO 13485-aligned quality management system; DHR (device history record) per lot
- ✓RoHS and REACH SVHC-free declaration on request
Manufacturing Process
Tubing and profiles are produced by cleanroom LSR extrusion with laser gauging for ID/OD control; molded cuffs, balloons and tips are produced on 85T-160T vertical LSR injection presses.
- Liquid material is metered and mixed in a closed system — no operator contact, no particulate ingress
- Post-curing in filtered ovens stabilizes elastomer properties and volatiles
- Assembly steps (tip bonding, hole punching, cuff overmolding) are performed in the same cleanroom cell
- Finished parts are double-bagged and lot-sealed for Ethylene Oxide or Gamma sterilization compatibility
Quality Inspection
- 🔍100% visual inspection (flash, short-shot, contamination) before packing
- 🔍Dimensional verification against approved drawing; FAI report on first shipment and after any tooling change
- 🔍Hardness per ASTM D2240 (Shore A) on every batch
- 🔍Lot traceability: material batch, cure records and operator logged for every carton
- 🔍Biocompatibility verification per ISO 10993 for the material grade, renewed on raw material change
- 🔍Burst pressure and leak testing on tubing samples per lot
- 🔍Tensile and elongation per ASTM D412 to confirm cure state
After-sales & Support
Every order ships with a Certificate of Conformance, First Article Inspection report and lot traceability records.
- Warranty: 12 months against material and workmanship defects
- Response: engineering reply within 24 hours, 8D report for confirmed quality issues
- Remedy: free replacement or credit for non-conforming batches; expedited re-shipment at our cost
- Support: free design-for-manufacturing review, material selection advice and sample policy for evaluation
- Recall readiness: full batch traceability enables targeted containment within 48 hours
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