ACS FUNNEL INTRODUCER

Introducer, Catheter

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Funnel Introducer.

Pre-market Notification Details

Device IDK875158
510k NumberK875158
Device Name:ACS FUNNEL INTRODUCER
ClassificationIntroducer, Catheter
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 CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-15
Decision Date1988-05-31

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