ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT

Wire, Guide, 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 Guide Wires With Modified Package Insert.

Pre-market Notification Details

Device IDK946029
510k NumberK946029
Device Name:ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
ContactMarianne Drennan
CorrespondentMarianne Drennan
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-09
Decision Date1995-02-24

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