MACROPORE CARDIO-WRAP (TS)

Pericardial Patch To Facilitate Revision Surgeries

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Cardio-wrap (ts).

Pre-market Notification Details

Device IDK031785
510k NumberK031785
Device Name:MACROPORE CARDIO-WRAP (TS)
ClassificationPericardial Patch To Facilitate Revision Surgeries
Applicant MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
ContactKenneth K Kleinhenz
CorrespondentKenneth K Kleinhenz
MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
Product CodeOMH  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-10
Decision Date2003-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18964050365047 K031785 000
18964050365023 K031785 000
18964050362046 K031785 000
18964050362022 K031785 000
00810057380266 K031785 000
00810057380259 K031785 000

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