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


Device Classification Name

catheter, continuous flush

510(k) Number K111490
Device Name MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
Applicant
EV3 INC
173 jefferson dr
menlo park, 
CA 
94025

Applicant Contact daniel cher, md
Correspondent
EV3 INC
173 jefferson dr
menlo park, 
CA 
94025

Correspodent Contact daniel cher, md
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 05/31/2011
Decision Date 09/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No