ACS ANGIOSCOPIC 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 Angioscopic Catheter.

Pre-market Notification Details

Device IDK905715
510k NumberK905715
Device Name:ACS ANGIOSCOPIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
ContactJane E Beggs
CorrespondentJane E Beggs
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-21
Decision Date1991-03-18

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