ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.

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 0.015 & 0.018 Pressure Guide Wire W/micro..

Pre-market Notification Details

Device IDK882507
510k NumberK882507
Device Name:ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMichael C Kolber
CorrespondentMichael C Kolber
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-17
Decision Date1989-03-31

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