.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP

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 .010 Hi-torque Guide Wires With Preshaped Tip.

Pre-market Notification Details

Device IDK911460
510k NumberK911460
Device Name:.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
ContactJane E Beggs
CorrespondentJane E Beggs
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-03
Decision Date1991-06-25

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