ACS INDEFLATOR PLUS (MODIFICATION #2)

Injector And Syringe, Angiographic

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Indeflator Plus (modification #2).

Pre-market Notification Details

Device IDK872981
510k NumberK872981
Device Name:ACS INDEFLATOR PLUS (MODIFICATION #2)
ClassificationInjector And Syringe, Angiographic
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 CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-31
Decision Date1987-10-20

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