SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES

Wire, Guide, Catheter

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Quest Floppy And Moderate Support Guide Wires.

Pre-market Notification Details

Device IDK980360
510k NumberK980360
Device Name:SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
ClassificationWire, Guide, Catheter
Applicant SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactJill Townsend
CorrespondentJill Townsend
SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-29
Decision Date1998-04-29
Summary:summary

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