LEMAITRE-BOOKWALTER VESSEL DEVICES

Dilator, Vessel, Surgical

VASCUTECH, INC.

The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre-bookwalter Vessel Devices.

Pre-market Notification Details

Device IDK912548
510k NumberK912548
Device Name:LEMAITRE-BOOKWALTER VESSEL DEVICES
ClassificationDilator, Vessel, Surgical
Applicant VASCUTECH, INC. 140 HAVERHILL ST. Andover,  MA  01810
ContactLisa A Pare
CorrespondentLisa A Pare
VASCUTECH, INC. 140 HAVERHILL ST. Andover,  MA  01810
Product CodeDWP  
CFR Regulation Number870.4475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-10
Decision Date1991-09-18

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