PhotoFix Decellularized Bovine Pericardium

Intracardiac Patch Or Pledget, Biologically Derived

CryoLife, Inc.

The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Photofix Decellularized Bovine Pericardium.

Pre-market Notification Details

Device IDK183635
510k NumberK183635
Device Name:PhotoFix Decellularized Bovine Pericardium
ClassificationIntracardiac Patch Or Pledget, Biologically Derived
Applicant CryoLife, Inc. 1655 Roberts Blvd. NW Kennesaw,  GA  30144
ContactHeather Emerick
CorrespondentHeather Emerick
CryoLife, Inc. 1655 Roberts Blvd. NW Kennesaw,  GA  30144
Product CodePSQ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-02-14
Summary:summary

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