UNBALLOON NON-OCCLUSION MODELING CATHETER

Catheter, Percutaneous

LEMAITRE VASCULAR, INC.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Unballoon Non-occlusion Modeling Catheter.

Pre-market Notification Details

Device IDK133026
510k NumberK133026
Device Name:UNBALLOON NON-OCCLUSION MODELING CATHETER
ClassificationCatheter, Percutaneous
Applicant LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington,  MA  01803
ContactAndrew Hodgkinson
CorrespondentAndrew Hodgkinson
LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington,  MA  01803
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-26
Decision Date2013-12-31
Summary:summary

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