ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT

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 Advanced Cardiovascular Systems Angioject.

Pre-market Notification Details

Device IDK844045
510k NumberK844045
Device Name:ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
ClassificationInjector And Syringe, Angiographic
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View,  CA  04043
ContactJane E Beggs
CorrespondentJane E Beggs
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View,  CA  04043
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-17
Decision Date1984-11-13

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