CorMatrix 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)

Intracardiac Patch Or Pledget, Biologically Derived

CorMatrix Cardiovascular, Inc.

The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Cormatrix 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).

Pre-market Notification Details

Device IDK181038
510k NumberK181038
Device Name:CorMatrix 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)
ClassificationIntracardiac Patch Or Pledget, Biologically Derived
Applicant CorMatrix Cardiovascular, Inc. 1100 Old Ellis Rd. Roswell,  GA  30076
ContactWendy Perreault
CorrespondentWendy Perreault
New South Regulatory, LLC 223 Coventry Road Decatur,  GA  30030
Product CodePSQ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-19
Decision Date2018-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850003965017 K181038 000
00850003965000 K181038 000

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