PERICARDIAL PATCH

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

AMERICAN EDWARDS LABORATORIES

The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Pericardial Patch.

Pre-market Notification Details

Device IDK833763
510k NumberK833763
Device Name:PERICARDIAL PATCH
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-26
Decision Date1984-11-01

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