ACS CORONARY GUIDING CATHETER

Catheter, Intravascular, Diagnostic

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Coronary Guiding Catheter.

Pre-market Notification Details

Device IDK861236
510k NumberK861236
Device Name:ACS CORONARY GUIDING CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMarianna Faist
CorrespondentMarianna Faist
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-02
Decision Date1986-07-10

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