SCIMED EXPO ANGIOGRAPHIC CATHETER

Catheter, Intravascular, Diagnostic

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Expo Angiographic Catheter.

Pre-market Notification Details

Device IDK951720
510k NumberK951720
Device Name:SCIMED EXPO ANGIOGRAPHIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactDeborah L Jensen
CorrespondentDeborah L Jensen
SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-14
Decision Date1995-06-22

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