Cleared Traditional

MatriStem UBM Pericardial Patch

K191734 · Acell, Inc. · Cardiovascular

Nov 2019

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K191734 is an FDA 510(k) clearance for the MatriStem UBM Pericardial Patch, a Intracardiac Patch Or Pledget, Biologically Derived (Class II — Special Controls, product code PSQ), submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on November 22, 2019, 147 days after receiving the submission on June 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K191734 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2019
Decision Date	November 22, 2019
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PSQ — Intracardiac Patch Or Pledget, Biologically Derived
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.3470
Definition	To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.