RIGHT CORONARY GUIDING CATHETER

Catheter, Percutaneous

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK833801
510k NumberK833801
Device Name:RIGHT CORONARY GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-01
Decision Date1984-03-12

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