MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS

Catheter, Continuous Flush

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Marksman Catheter, *refers To Different Catheter Working Lenghts, Distal Single Coiled Lengths And Distal Shaft Lengths.

Pre-market Notification Details

Device IDK111490
510k NumberK111490
Device Name:MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
ClassificationCatheter, Continuous Flush
Applicant EV3 INC 173 JEFFERSON DR Menlo Park,  CA  94025
ContactDaniel Cher, Md
CorrespondentDaniel Cher, Md
EV3 INC 173 JEFFERSON DR Menlo Park,  CA  94025
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-31
Decision Date2011-09-16
Summary:summary

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