CATHLAB SILICONE BILIARY BALLOON CATHETER

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

CATHLAB CORP.

The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Cathlab Silicone Biliary Balloon Catheter.

Pre-market Notification Details

Device IDK910917
510k NumberK910917
Device Name:CATHLAB SILICONE BILIARY BALLOON CATHETER
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant CATHLAB CORP. 17991 FITCH Irvine,  CA  92714
ContactDaniel R Lucas
CorrespondentDaniel R Lucas
CATHLAB CORP. 17991 FITCH Irvine,  CA  92714
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-05
Decision Date1991-08-02

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