LEMAITRE RETROGRADE VALVULOTOME

Valvulotome

VASCUTECH, INC.

The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Retrograde Valvulotome.

Pre-market Notification Details

Device IDK924171
510k NumberK924171
Device Name:LEMAITRE RETROGRADE VALVULOTOME
ClassificationValvulotome
Applicant VASCUTECH, INC. 140 HAVERHILL ST. Andover,  MA  01810
ContactGeorge W Lemaitre
CorrespondentGeorge W Lemaitre
VASCUTECH, INC. 140 HAVERHILL ST. Andover,  MA  01810
Product CodeMGZ  
CFR Regulation Number870.4885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-18
Decision Date1993-02-16

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