ALBOSURE POLYESTER VASCULAR PATCH

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

LEMAITRE VASCULAR, INC.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Albosure Polyester Vascular Patch.

Pre-market Notification Details

Device IDK101740
510k NumberK101740
Device Name:ALBOSURE POLYESTER VASCULAR PATCH
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington,  MA  01803
ContactVic Zhang
CorrespondentVic Zhang
LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington,  MA  01803
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-21
Decision Date2010-09-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840663105021 K101740 000
00840663104895 K101740 000
00840663104802 K101740 000
00840663104765 K101740 000
00840663104604 K101740 000
00840663104543 K101740 000

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