INTIMAX(TM) IRRIGATION CATHETER

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

APPLIED VASCULAR DEVICES, INC.

The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Intimax(tm) Irrigation Catheter.

Pre-market Notification Details

Device IDK911181
510k NumberK911181
Device Name:INTIMAX(TM) IRRIGATION CATHETER
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills,  CA  92653
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-18
Decision Date1991-04-18

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