HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Wire, Guide, Catheter

GUIDANT CORP.

The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Balance Iniversal Guide Wire With Hydrocoat Hydrophilic Coating.

Pre-market Notification Details

Device IDK031678
510k NumberK031678
Device Name:HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
ClassificationWire, Guide, Catheter
Applicant GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591
ContactBruce Cerwin
CorrespondentBruce Cerwin
GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-30
Decision Date2003-08-26
Summary:summary

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