ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES

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 Hi-torque Tapered Diameter Guide Wires.

Pre-market Notification Details

Device IDK854830
510k NumberK854830
Device Name:ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactJane E Beggs
CorrespondentJane E Beggs
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 Received1985-12-03
Decision Date1986-03-31

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