ACS HI-TORQUE FLEX-T 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 Hi-torque Flex-t Guide Wire.

Pre-market Notification Details

Device IDK862360
510k NumberK862360
Device Name:ACS HI-TORQUE FLEX-T GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMarianna Faist
CorrespondentMarianna Faist
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 Received1986-06-23
Decision Date1986-09-11

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