Identity
- Trade Name
- Hemapatch FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Hemapatch Knitted Collagen Coated Vascular Patch FDA UDI
- Model / Reference
- HEK100/100P (1) FDA UDI
- Description
- Hemapatch Knitted Collagen Coated Vascular Patch FDA UDI
Identifiers
- Catalog Number
- HEK100/100P (1) FDA UDI
- Primary DI / UDI-DI
- 00384401001522 FDA UDI
- 510(k) Number
- K964625 FDA UDI
- FDA Product Code
- DSY FDA UDI
- GMDN Term
- Cardiovascular patch, animal-derived 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
- Length — 100 Millimeter FDA UDIWidth — 100 Millimeter FDA UDI
Category: Cardiovascular patch, animal-derived
Hemapatch by Intervascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular patch, animal-derived.
- Biotronik BioEnvelope — Elutia Med LLC · Class II
- XenoSure Biologic Patch — LeMaitre Vascular, Inc. · Class II
- CardioCel Bioscaffold Patch 5 cm X 8 cm — LeMaitre Vascular, Inc. · Class II
- VASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- Invengenx — Tisgenx · Class II
- VascuCel — ADMEDUS REGEN PTY LTD · Class II
- AlboSure Vascular Patch — LeMaitre Vascular, Inc. · Class II
- XenoSure Biologic Patch — LeMaitre Vascular, Inc. · 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 |
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Manufacturer
- Manufacturer
- Intervascular, Inc.
Sources (1)
- FDA UDI 86041c5c-007c-400a-8863-2f6303cf4430 38 fields · synced May 31, 2026