ADVANCED CARDIOVASCULAR-CORONARY GUID

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 Advanced Cardiovascular-coronary Guid.

Pre-market Notification Details

Device IDK842195
510k NumberK842195
Device Name:ADVANCED CARDIOVASCULAR-CORONARY GUID
ClassificationCatheter, Intravascular, Diagnostic
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-04
Decision Date1984-07-13

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