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FDA 510(k)

PhotoFix Decellularized Bovine Pericardium

K-Number: K183635 · 2019-02-14

ApplicantCryolife, Inc.
Decision Date2019-02-14
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PhotoFix Decellularized Bovine Pericardium is a medical device manufactured by Cryolife, Inc.. It received FDA 510(k) clearance on 2019-02-14 under approval number K183635. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PhotoFix Decellularized Bovine Pericardium?

PhotoFix Decellularized Bovine Pericardium is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by Cryolife, Inc.. The 510(k) number is K183635.

When was PhotoFix Decellularized Bovine Pericardium approved by the FDA?

PhotoFix Decellularized Bovine Pericardium received FDA 510(k) clearance on 2019-02-14, under approval number K183635.

What company makes PhotoFix Decellularized Bovine Pericardium?

PhotoFix Decellularized Bovine Pericardium is manufactured by Cryolife, Inc..

What is the FDA product code for PhotoFix Decellularized Bovine Pericardium?

The FDA product code for PhotoFix Decellularized Bovine Pericardium is PSQ.

Other Devices by Cryolife, Inc.

K172085PhotoFix Decellularized Bovine Pericardium K162506PhotoFix Decellularized Bovine Pericardium PMA P010003Glue, surgical, arteries PMA P970029SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION

Related Devices (Code: PSQ)

K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC K170951CardioCel 3DAdmedus Regen Pty, Ltd. K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)Cormatrix Cardiovascular, Inc. K191734MatriStem UBM Pericardial PatchAcell, Inc. K200566ADAPT TissueAdmedus Regen Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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