SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE

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 Choice Pt Exchange Extra Support Ptca And Long Taper Ptca Guide Wire.

Pre-market Notification Details

Device IDK960657
510k NumberK960657
Device Name:SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactConnie J Del Toro
CorrespondentConnie J Del Toro
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 Received1996-02-16
Decision Date1996-04-29
Summary:summary

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