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FDA 510(k)

MatriStem UBM Pericardial Patch

K-Number: K191734 · 2019-11-22

ApplicantAcell, Inc.
Decision Date2019-11-22
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MatriStem UBM Pericardial Patch is a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K191734. 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 MatriStem UBM Pericardial Patch?

MatriStem UBM Pericardial Patch is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Acell, Inc.. The 510(k) number is K191734.

When was MatriStem UBM Pericardial Patch approved by the FDA?

MatriStem UBM Pericardial Patch received FDA 510(k) clearance on 2019-11-22, under approval number K191734.

What company makes MatriStem UBM Pericardial Patch?

MatriStem UBM Pericardial Patch is manufactured by Acell, Inc..

What is the FDA product code for MatriStem UBM Pericardial Patch?

The FDA product code for MatriStem UBM Pericardial Patch is PSQ.

Other Devices by Acell, Inc.

K162554Gentrix Surgical Matrix K153754MicroMatrix K172399MicroMatrix K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend K180776Cytal Wound Particulate K192725Cytal Wound Matrix 3-Layer

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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. 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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