HI-TOQUE WHISPER LS AND MS 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-toque Whisper Ls And Ms Guide Wire With Hydrocoat Hydrophilic Coating.

Pre-market Notification Details

Device IDK013092
510k NumberK013092
Device Name:HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
ClassificationWire, Guide, Catheter
Applicant GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591 -4630
ContactJennifer P Riggs
CorrespondentJennifer P Riggs
GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591 -4630
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-17
Decision Date2001-12-13
Summary:summary

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