PSQ · Intracardiac Patch Or Pledget, Biologically Derived
Cardiovascular · 21 CFR 870.3470 · Class 2
Overview
| Product Code | PSQ |
|---|---|
| Device Name | Intracardiac Patch Or Pledget, Biologically Derived |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | Oct 19, 2022 | SESE |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | Oct 19, 2022 | SESE |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | Dec 21, 2021 | SESE |
| K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | Apr 3, 2020 | SESE |
| K190882 | XenoSure Biologic Patch | Lemaitre Vascular | Feb 13, 2020 | SESE |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | Nov 22, 2019 | SESE |
| K183635 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Feb 14, 2019 | SESE |
| 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. | Oct 10, 2018 | SESE |
| K172085 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | Dec 4, 2017 | SESE |
| K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | Nov 17, 2017 | SESE |
| K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | Apr 28, 2017 | SESE |
Top Applicants
- Admedus Regen Pty, Ltd. — 2 clearances
- Cryolife, Inc. — 2 clearances
- Synovis Life Technologies, Inc. — 2 clearances
- Acell, Inc. — 1 clearance
- Cormatrix Cardiovascular, Inc. — 1 clearance
