exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
FDA 510(k)Class II (US FDA 510(k))
by Peca Labs
Identifiers
- 510(k) Number
- K202471 FDA 510(k)
- FDA Product Code
- DSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3450 FDA 510(k)
- Regulation Number
- 870.3450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The exGraft ePTFE Vascular Graft and exGraft Carbon ePTFE Vascular Graft are synthetic vascular prostheses classified as Prosthesis, Vascular Graft, of 6mm and Greater Diameter. These devices are manufactured from expanded polytetrafluoroethylene (ePTFE) and are designed to replace or bypass diseased blood vessels in patients with occlusive or aneurysmal conditions. The ePTFE material provides durability and biocompatibility for long-term vascular support.
These grafts are supplied sterile and intended for single-use in surgical procedures. The exGraft Carbon variant includes a radio-opaque design to enhance visibility during implantation and follow-up imaging. The devices are regulated under FDA 510(k) clearance (K202471) and fall under Class II medical devices (regulation number 870.3450). They are available in multiple sizes as indicated by the registration numbers and are intended for use in cardiovascular surgical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF PECA Labs in collaboration with Visionary Medtech Presents ex-Graft A ..., EXGRAFT Peca Labs - LeviBio, exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202471 | Class II | Active |
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Manufacturer
- Manufacturer
- Peca Labs
Sources (1)
- FDA 510(k) K202471 24 fields · synced Oct 6, 2026