ACS(R) HI-TORQUE GOLD(TM) 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 Acs(r) Hi-torque Gold(tm) Guide Wire.

Pre-market Notification Details

Device IDK884262
510k NumberK884262
Device Name:ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
ContactKevin Corrrigan
CorrespondentKevin Corrrigan
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-11
Decision Date1988-12-21

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