ACS ANGIOTRAK(TM) SYSTEM

Syringe, Balloon Inflation

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Angiotrak(tm) System.

Pre-market Notification Details

Device IDK921719
510k NumberK921719
Device Name:ACS ANGIOTRAK(TM) SYSTEM
ClassificationSyringe, Balloon Inflation
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
ContactKevin Corrigan
CorrespondentKevin Corrigan
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-09
Decision Date1992-08-07

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