THE SAMUELS RETROGRAD VALVULOTOME

Valvulotome

VASCUTECH, INC.

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

Pre-market Notification Details

Device IDK932009
510k NumberK932009
Device Name:THE SAMUELS RETROGRAD VALVULOTOME
ClassificationValvulotome
Applicant VASCUTECH, INC. 790 TURNPIKE ST. North Andover,  MA  01845
ContactGeorge W Lemaitre
CorrespondentGeorge W Lemaitre
VASCUTECH, INC. 790 TURNPIKE ST. North Andover,  MA  01845
Product CodeMGZ  
CFR Regulation Number870.4885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-23
Decision Date1993-09-21

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