FDA Product Code
FDA Product Code PSQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3470
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | Traditional | PDF ↗ |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2022-10-19 | Traditional | PDF ↗ |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | 2020-04-03 | Special | PDF ↗ |
| K190882 | XenoSure Biologic Patch | Lemaitre Vascular | 2020-02-13 | Traditional | PDF ↗ |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | 2019-11-22 | Traditional | PDF ↗ |
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2019-02-14 | Special | PDF ↗ |
| K181038 | 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) | Cormatrix Cardiovascular, Inc. | 2018-10-10 | Traditional | PDF ↗ |
| K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-12-04 | Traditional | PDF ↗ |
| K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | 2017-11-17 | Traditional | PDF ↗ |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | 2017-04-28 | Special | PDF ↗ |
Product code PSQ · Class II · Cardiovascular. Data: openFDA.