PSQ
11 FDA 510(k) clearances · Product code
147 daysmedian time to decision
315 days90th percentile
11clearances measured
FDA profile
- Official device name
- Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- Flags
- Implant
- FDA definition
- To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| XenoSure Biologic Patch (K190882) | Lemaitre Vascular | 2020-02-13 |
| 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 |
Track PSQ automatically
Every clearance here is in the API, with alerts when new ones post.