ACS TOURGIDE GUIDING CATHETER

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 Tourgide Guiding Catheter.

Pre-market Notification Details

Device IDK953987
510k NumberK953987
Device Name:ACS TOURGIDE GUIDING CATHETER
ClassificationCatheter, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
ContactMarianne C Drennan
CorrespondentMarianne C Drennan
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-23
Decision Date1995-12-07

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