ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA

Catheter, Continuous Flush

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow Hpc Flow Directed Micro Catheter, Reba.

Pre-market Notification Details

Device IDK093750
510k NumberK093750
Device Name:ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
ClassificationCatheter, Continuous Flush
Applicant EV3 INC 9775 TOLEDO WAY Irvine,  CA  92618
ContactLaura Heaton
CorrespondentLaura Heaton
EV3 INC 9775 TOLEDO WAY Irvine,  CA  92618
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-07
Decision Date2009-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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