MatriStem UBM Pericardial Patch

Intracardiac Patch Or Pledget, Biologically Derived

Acell, Inc.

The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Matristem Ubm Pericardial Patch.

Pre-market Notification Details

Device IDK191734
501k NumberK191734
Device Name:MatriStem UBM Pericardial Patch
ClassificationIntracardiac Patch Or Pledget, Biologically Derived
Applicant Acell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia,  MD  21046
ContactMichelle Huettner
CorrespondentMichelle Huettner
Acell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia,  MD  21046
Product CodePSQ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-28
Decision Date2019-11-22

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