SCIMED 6F 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 6f Angiographic Catheter.

Pre-market Notification Details

Device IDK932542
510k NumberK932542
Device Name:SCIMED 6F ANGIOGRAPHIC CATHETER
ClassificationCatheter, Intravascular, Diagnostic
Applicant SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove,  MN  55311 -3616
ContactDarlene Thometz
CorrespondentDarlene Thometz
SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove,  MN  55311 -3616
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-26
Decision Date1993-08-11

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