DUAL LUMEN CATHETER, MODEL DL-35-90

Catheter, Percutaneous

ENDOLOGIX, INC.

The following data is part of a premarket notification filed by Endologix, Inc. with the FDA for Dual Lumen Catheter, Model Dl-35-90.

Pre-market Notification Details

Device IDK991601
510k NumberK991601
Device Name:DUAL LUMEN CATHETER, MODEL DL-35-90
ClassificationCatheter, Percutaneous
Applicant ENDOLOGIX, INC. 20 FAIRBANKS, SUITE #173 Irvine,  CA  92618
ContactKaren U Salinas
CorrespondentKaren U Salinas
ENDOLOGIX, INC. 20 FAIRBANKS, SUITE #173 Irvine,  CA  92618
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-10
Decision Date1999-10-28

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