ACS INDEFLATOR P/T 20

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 P/t 20.

Pre-market Notification Details

Device IDK883452
510k NumberK883452
Device Name:ACS INDEFLATOR P/T 20
ClassificationInjector And Syringe, Angiographic
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactKevyn B O'connor
CorrespondentKevyn B O'connor
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-12
Decision Date1988-10-14

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