PhotoFix Decellularized Bovine Pericardium
FDA 510(k) K162506 · Cryolife, Inc.
510(k) numberK162506
Submission
- Device name
- PhotoFix Decellularized Bovine Pericardium
- Applicant
- Cryolife, Inc.
Kennesaw, GA, US - Received
- September 8, 2016
- Decision date
- March 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXZ
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|---|---|---|---|
| K240775 | PeriBeam® Pericardial MembraneDXZ · Traditional | Tamabio | 04/18/2025SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | Vascutek, Ltd. | 07/08/2020SE |
| K162579 | VascuCelDXZ · Special | Admedus Regen Pty, Ltd. | 10/14/2016SE |
| K152127 | CorMatrix TykeDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 02/04/2016SE |
| K151865 | PremiPatch PTFE PledgetDXZ · Traditional | Aesculap, Inc. | 10/27/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 11/25/2014SE |
| K140789 | Cormatrix Ecm for Vascular RepairDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 07/15/2014SE |
| K130872 | CardiocelDXZ · Traditional | Celxcel Pty, Ltd. | 01/30/2014SE |
| K122306 | Synovis Collagen Matrix (TBD)DXZ · Traditional | Synovis Surgical Innovations | 03/08/2013SE |
More from Synovis Surgical Innovations
| 510(k) | Device | Decision |
|---|---|---|
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | 02/14/2019SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | 12/04/2017SE |
| 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 (K162506) received a 510(k) decision of Substantially Equivalent on March 9, 2017, 182 days after the submission was received.
What is the product code of K162506?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.