SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION

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 6 French Angiographic Catheter Modification.

Pre-market Notification Details

Device IDK934541
510k NumberK934541
Device Name:SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
ClassificationCatheter, Intravascular, Diagnostic
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 CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-16
Decision Date1994-05-12

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