PSQ — Intracardiac Patch Or Pledget, Biologically Derived Class II
FDA product code PSQ covers "Intracardiac Patch Or Pledget, Biologically Derived", a Class II medical device regulated under 21 CFR 870.3470. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
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 |