PSQ — Intracardiac Patch Or Pledget, Biologically Derived Class II
Classification Details
- Product Code
- PSQ
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221029 | synovis life technologies | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | October 19, 2022 |
| K221032 | synovis life technologies | Vascu-Guard Vascular Repair Patch | October 19, 2022 |
| K210331 | helios cardio | CardiaMend Pericardial and Epicardial Reconstruction Matrix | December 21, 2021 |
| K200566 | admedus regen pty | ADAPT Tissue | April 3, 2020 |
| K190882 | lemaitre vascular | XenoSure Biologic Patch | February 13, 2020 |
| K191734 | acell | MatriStem UBM Pericardial Patch | November 22, 2019 |
| K183635 | cryolife | PhotoFix Decellularized Bovine Pericardium | February 14, 2019 |
| K181038 | cormatrix cardiovascular | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm | October 10, 2018 |
| K172085 | cryolife | PhotoFix Decellularized Bovine Pericardium | December 4, 2017 |
| K172660 | edwards lifesciences | Duravess bovine pericardial vascular patch | November 17, 2017 |
| K170951 | admedus regen pty | CardioCel 3D | April 28, 2017 |