Identity
- Trade Name
- GORE-TEX Stretch Vascular Graft FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- STRETCH VASCULAR GRAFT SW 14mmX20cm FDA UDI
- Model / Reference
- SA1402 FDA UDI
- Description
- STRETCH VASCULAR GRAFT SW 14mmX20cm FDA UDI
Identifiers
- Catalog Number
- SA1402 FDA UDI
- Primary DI / UDI-DI
- 00733132611577 FDA UDI
- 510(k) Number
- K903931 FDA UDI
- FDA Product Code
- DSY FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDILumen/Inner Diameter — 14 Millimeter FDA UDI
Category: Synthetic vascular graft
GORE-TEX Stretch Vascular Graft by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic vascular graft.
- Gelweave™ — VASCUTEK LTD · Class II
- Gelweave™ — VASCUTEK LTD · Class II
- COOK — William Cook Europe ApS · Class III
- Gelweave™ — VASCUTEK LTD · Class II
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
- Gelweave Vascular Prostheses — VASCUTEK LTD · Class II
- IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular · Class II
Cleared under the same submission
K903931 also covers:
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
- GORE-TEX Stretch Vascular Graft — W. L. GORE & ASSOCIATES, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 8e9e8c5c-69c4-4c45-974e-4b37499fa000 37 fields · synced May 31, 2026