PhotoFix Decellularized Bovine Pericardium
FDA 510(k) K183635 · Cryolife, Inc.
510(k) numberK183635
Submission
- Device name
- PhotoFix Decellularized Bovine Pericardium
- Applicant
- Cryolife, Inc.
Kennesaw, GA, US - Received
- December 26, 2018
- Decision date
- February 14, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSQ – Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
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| K221032 | Vascu-Guard Vascular Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
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| K210331 | CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional | Helios Cardio, Inc. | 12/21/2021SE |
| K200566 | ADAPT TissuePSQ · Special | Admedus Regen Pty, Ltd. | 04/03/2020SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | Lemaitre Vascular | 02/13/2020SE |
| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | Acell, Inc. | 11/22/2019SE |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…PSQ · Traditional | Cormatrix Cardiovascular, Inc. | 10/10/2018SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | Cryolife, Inc. | 12/04/2017SE |
| K172660 | Duravess bovine pericardial vascular patchPSQ · Traditional | Edwards Lifesciences, LLC | 11/17/2017SE |
| K170951 | CardioCel 3DPSQ · Special | Admedus Regen Pty, Ltd. | 04/28/2017SE |
More from Admedus Regen Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | 12/04/2017SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | 03/09/2017SE |
| K132105 | Perclot TopicalQSY · Traditional | 04/03/2014SE |
| K110581 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 01/10/2012SE |
| K101587 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 09/16/2010SE |
| K101866 | Cryopatch SG Pulmonary Human Cardiac PatchDXZ · Special | 07/23/2010SE |
| K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit)OHA · Traditional | 05/25/2010SE |
| K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchDXZ · Traditional | 08/07/2009SE |
| K083106 | Cryovalve SG Pulmonary Valve and ConduitOHA · Traditional | 02/06/2009SE |
| K033484 | Human Heart Valve, Cryovalve SGOHA · Traditional | 02/07/2008SE |
Questions and answers
When was PhotoFix Decellularized Bovine Pericardium cleared by the FDA?
PhotoFix Decellularized Bovine Pericardium (K183635) received a 510(k) decision of Substantially Equivalent on February 14, 2019, 50 days after the submission was received.
What is the product code of K183635?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.