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Xenosure Biologic Patch
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 0.6BV8Model 08406631XenoSureKA510(k) K190882
Identity
- Trade Name
- XenoSure Biologic Patch FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Xenosure Biologic Patch EUDAMEDXenoSure Biologic Patch, 0.6cmx8cm FDA UDI
- Model / Reference
- 08406631XenoSureKA EUDAMED0.6BV8 EUDAMEDFDA UDI
- Description
- XenoSure Biologic Patch, 0.6cmx8cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840663106745 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840663106745 EUDAMED
- 510(k) Number
- K040835 FDA UDI
- FDA Product Code
- FTM FDA UDI
- EMDN Code
- P07020101 PERICARDIUM VASCULAR PATCHES EUDAMED
- GMDN Term
- Cardiovascular patch, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Safe FDA UDI
Xenosure Biologic Patch by LeMaitre Vascular, Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190882 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00840663106745 | Class III | Active |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- FDA Applicant
- Lemaitre Vascular
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (3)
- EUDAMED 25d33e65-6279-40fd-a764-56fbfb2a065e 85 fields · synced Jun 19, 2026
- FDA UDI 349bc61f-bb8b-4981-a085-1e1e19876555 34 fields · synced May 29, 2026
- FDA 510(k) K190882 1 fields · synced May 18, 2026