GUIDE WIRE

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 Guide Wire.

Pre-market Notification Details

Device IDK821190
510k NumberK821190
Device Name:GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-27
Decision Date1982-08-31

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