XenoSure Biologic Patch
FDA 510(k) clearance K190882 · decided 2020-02-13
Clearance details
- K-number
- K190882
- Device name
- XenoSure Biologic Patch
- Applicant
- Lemaitre Vascular
- Decision
- Substantially Equivalent
- Date received
- 2019-04-04
- Decision date
- 2020-02-13
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- PSQ
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vascu-Guard Vascular Repair Patch (K221032) | Synovis Life Technologies, Inc. | 2022-10-19 |
| PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (K221029) | Synovis Life Technologies, Inc. | 2022-10-19 |
| CardiaMend Pericardial and Epicardial Reconstruction Matrix (K210331) | Helios Cardio, Inc. | 2021-12-21 |
| ADAPT Tissue (K200566) | Admedus Regen Pty, Ltd. | 2020-04-03 |
| MatriStem UBM Pericardial Patch (K191734) | Acell, Inc. | 2019-11-22 |
| PhotoFix Decellularized Bovine Pericardium (K183635) | Cryolife, Inc. | 2019-02-14 |
| CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (K181038) | Cormatrix Cardiovascular, Inc. | 2018-10-10 |
| PhotoFix Decellularized Bovine Pericardium (K172085) | Cryolife, Inc. | 2017-12-04 |
| Duravess bovine pericardial vascular patch (K172660) | Edwards Lifesciences, LLC | 2017-11-17 |
| CardioCel 3D (K170951) | Admedus Regen Pty, Ltd. | 2017-04-28 |
Recalls involving this device
No recalls on record reference this clearance.