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FDA 510(k), K172085, PhotoFix Decellularized Bovine Pericardium
FDA 510(k), K172085, PhotoFix Decellularized Bovine Pericardium
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510(K) Number: K172085
Device Name: PhotoFix Decellularized Bovine Pericardium
Manufacturer: CryoLife, Inc.
Device Classification Name: intracardiac patch or pledget, biologically derived
Regulation Number: 870.3470
Classification Product Code: PSQ
Date Received: 07/11/2017
Decision Date: 12/04/2017
Regulation Medical Specialty: Cardiovascular
Device Name: PhotoFix Decellularized Bovine Pericardium
Manufacturer: CryoLife, Inc.
Device Classification Name: intracardiac patch or pledget, biologically derived
Regulation Number: 870.3470
Classification Product Code: PSQ
Date Received: 07/11/2017
Decision Date: 12/04/2017
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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