010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF

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-tor Inter/stand Guidwire Preshape Tip/modif.

Pre-market Notification Details

Device IDK914828
510k NumberK914828
Device Name:010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
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 Received1991-10-24
Decision Date1992-01-08

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