SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER

Catheter, Continuous Flush

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) Coronary Guide Wire Exchange/infusion Catheter.

Pre-market Notification Details

Device IDK945593
510k NumberK945593
Device Name:SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
ClassificationCatheter, Continuous Flush
Applicant SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactSherry L Sparrow
CorrespondentSherry L Sparrow
SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-14
Decision Date1995-01-13

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