SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER

Catheter, Percutaneous

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 8 French Big-max Guide Catheter.

Pre-market Notification Details

Device IDK943777
510k NumberK943777
Device Name:SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
ClassificationCatheter, Percutaneous
Applicant SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove,  MN  55311 -1566
ContactDiane M Lowe
CorrespondentDiane M Lowe
SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove,  MN  55311 -1566
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-02
Decision Date1994-10-13

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