ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST

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 Et Hi-flow Soft Tip/et Hi-flow/enhanced Torque St.

Pre-market Notification Details

Device IDK882803
510k NumberK882803
Device Name:ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
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 Received1988-07-07
Decision Date1988-09-16

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