Identity
- Trade Name
- Duravess FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Bovine pericardial vascular patch FDA UDI
- Model / Reference
- DP1X6 FDA UDI
- Description
- Bovine pericardial vascular patch FDA UDI
Identifiers
- Catalog Number
- DP1X6 FDA UDI
- Primary DI / UDI-DI
- 00690103199031 FDA UDI
- 510(k) Number
- K172660 FDA UDI
- FDA Product Code
- PSQ FDA UDI
- GMDN Term
- Cardiovascular patch, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3470 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiovascular patch, animal-derived
Duravess by Edwards Lifesciences LLC — 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
K172660 also covers:
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI f7a30aec-3c4e-48c9-b059-40d8e2cf2bd4 38 fields · synced Jun 8, 2026