Identity
- Trade Name
- Hemagard FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Hemagard Knitted Straight Collagen Coated Vascular Graft FDA UDI
- Model / Reference
- HGK0010-100 FDA UDI
- Description
- Hemagard Knitted Straight Collagen Coated Vascular Graft FDA UDI
Identifiers
- Catalog Number
- HGK0010-100 FDA UDI
- Primary DI / UDI-DI
- 00384401015093 FDA UDI
- 510(k) Number
- K964625 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 10 Millimeter FDA UDILength — 100 Centimeter FDA UDI
Category: Synthetic vascular graft
Hemagard is an implantable synthetic vascular graft designed to replace or bypass diseased or injured blood vessels, typically the aorta, iliac, femoral, or popliteal arteries. Made from woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics, it is not intended for use in the coronary arteries.
Similar devices
Also classified as Synthetic vascular graft.
- Gelweave™ — VASCUTEK LTD · Class II
- GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
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- 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
Cleared under the same submission
K964625 also covers:
- Hemacarotid Patch — Intervascular, Inc.
- Hemacarotid Patch — Intervascular, Inc.
- Hemacarotid Patch — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, Inc.
- Hemagard — Intervascular, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intervascular, Inc.
Sources (1)
- FDA UDI 2ffc2169-7b9c-4901-aa8c-714e2a21b287 38 fields · synced Jul 26, 2026