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FDA 510(k)

Duravess bovine pericardial vascular patch

K-Number: K172660 · 2017-11-17

ApplicantEdwards Lifesciences, LLC
Decision Date2017-11-17
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Duravess bovine pericardial vascular patch is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-11-17 under approval number K172660. 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 Duravess bovine pericardial vascular patch?

Duravess bovine pericardial vascular patch is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K172660.

When was Duravess bovine pericardial vascular patch approved by the FDA?

Duravess bovine pericardial vascular patch received FDA 510(k) clearance on 2017-11-17, under approval number K172660.

What company makes Duravess bovine pericardial vascular patch?

Duravess bovine pericardial vascular patch is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Duravess bovine pericardial vascular patch?

The FDA product code for Duravess bovine pericardial vascular patch is PSQ.

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Related Devices (Code: PSQ)

K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. 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. K183635PhotoFix Decellularized Bovine PericardiumCryolife, 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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