ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH

Catheter, Percutaneous

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Et Hi-flow/enhanced Torque Coronary Guid Cath.

Pre-market Notification Details

Device IDK926421
510k NumberK926421
Device Name:ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
ClassificationCatheter, Percutaneous
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 CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-23
Decision Date1993-03-23

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