XenoSure Biologic Patch

Intracardiac Patch Or Pledget, Biologically Derived

LeMaitre Vascular

The following data is part of a premarket notification filed by Lemaitre Vascular with the FDA for Xenosure Biologic Patch.

Pre-market Notification Details

Device IDK190882
510k NumberK190882
Device Name:XenoSure Biologic Patch
ClassificationIntracardiac Patch Or Pledget, Biologically Derived
Applicant LeMaitre Vascular 63 Second Avenue Burlington,  MA  01803
ContactJohn N. Bradsher
CorrespondentJohn N. Bradsher
LeMaitre Vascular 63 Second Avenue Burlington,  MA  01803
Product CodePSQ  
Subsequent Product CodeFTM
Subsequent Product CodeMFX
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-04
Decision Date2020-02-13

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