Precision-engineered for safe, reliable access in percutaneous arterial and venous procedures — fully customized to your clinical protocol and engineering drawings.
The Vascular Introducer Sheath is a sterile, single-use medical device manufactured under ISO 13485 and ISO 9001 quality management systems. Designed exclusively per customer-supplied engineering drawings, it delivers precise, repeatable performance for interventional cardiology, radiology, and vascular surgery applications.
Each unit is built to your exact specifications — no standard sizes, no off-the-shelf compromises. Validated for biocompatibility (ISO 10993-1, -4, -5, -10, -11), sterilization (ISO 11135), and mechanical integrity, it meets the highest clinical reliability standards without sacrificing design flexibility.
No generic sizing — every sheath is produced strictly from your approved technical drawings, ensuring full dimensional and functional alignment with your clinical or system requirements.
Polished PTFE-lined inner surface ensures minimal friction (<0.05 coefficient), enabling effortless wire and catheter passage with reduced risk of intimal injury.
Validated to withstand ≥300 psi hydrostatic pressure — compatible with power injectors and contrast delivery systems used in angiography and CT perfusion.
| Parameter | Specification |
|---|---|
| Sizing | Fully custom — fabricated per client-provided engineering drawings; no standard sizes |
| Dimensional Configuration | Custom sizes available; configurable per protocol |
| Inner Diameter Tolerance | ±0.02 mm (tight control for consistent flow) |
| Material Composition | Shaft: Pebax® 72D + stainless steel braid; Hub: Medical-grade polycarbonate |
| Sterilization | EO sterilized; validated per ISO 11135 |
| Biocompatibility | ISO 10993-1, -4, -5, -10, -11 compliant |
| Quality Certification | Manufactured under ISO 13485 and ISO 9001 certified QMS |
We support full OEM/ODM integration for hospitals, distributors, and device manufacturers — from private-label packaging to bespoke dimensional engineering based entirely on your technical documentation.
Yes — validated for use with contrast media injectors up to 300 psi and flow rates ≥5 mL/sec, meeting ACR and SCVIR guidelines.
No — all units are manufactured exclusively to your engineering drawings. There are no pre-defined sizes, lengths, or configurations.
Each shipment includes lot-specific CoA, EO sterilization report, ISO 13485 manufacturing certificate, and full traceability to your original drawing revision. Regulatory dossiers available under NDA.
Contact our clinical engineering team for technical consultation, sample requests, or OEM collaboration — all based on your specifications.
