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FDA 510(k), K183635, PhotoFix Decellularized Bovine Pericardium
FDA 510(k), K183635, PhotoFix Decellularized Bovine Pericardium
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510(K) Number: K183635
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: 12/26/2018
Decision Date: 02/14/2019
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: 12/26/2018
Decision Date: 02/14/2019
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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