ACS RX SUPPORT 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 Rx Support Catheter.

Pre-market Notification Details

Device IDK911957
510k NumberK911957
Device Name:ACS RX SUPPORT CATHETER
ClassificationCatheter, Intravascular, Diagnostic
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 CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-02
Decision Date1991-09-06

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