LEMAITRE BILIARY CATHETER

Dislodger, Stone, Biliary

VASCUTECH, INC.

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

Pre-market Notification Details

Device IDK992941
510k NumberK992941
Device Name:LEMAITRE BILIARY CATHETER
ClassificationDislodger, Stone, Biliary
Applicant VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington,  MA  01803
ContactTrent G Kamke
CorrespondentTrent G Kamke
VASCUTECH, INC. 164 MIDDLESEX TURNPIKE Burlington,  MA  01803
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-31
Decision Date2000-01-12

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