SCIMED(R) CHOICE(TM) PT EXCHANGE 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(r) Choice(tm) Pt Exchange Ptca Guide Wire.

Pre-market Notification Details

Device IDK950266
510k NumberK950266
Device Name:SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth,  MN  55441 -2644
ContactDeborah L Jensen
CorrespondentDeborah L Jensen
SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth,  MN  55441 -2644
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-23
Decision Date1995-04-14

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