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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 the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) 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. The listed applicant is Acell, Inc.. The 510(k) number is K191734.

When did MatriStem UBM Pericardial Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for MatriStem UBM Pericardial Patch?

The FDA 510(k) record lists Acell, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Acell, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241724Cytal® Wound Matrix; Cytal® Burn MatrixK241706MicroMatrix® UBM ParticulateK230980MicroMatrix® FlexK192725Cytal Wound Matrix 3-LayerK182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalK180776Cytal Wound Particulate

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Related Devices (Code: PSQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.K200566ADAPT TissueAdmedus Regen Pty, Ltd.K190882XenoSure Biologic PatchLemaitre VascularK183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

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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