MERIT MARQUIS FLOW SWITCH


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K110643
Device Name MERIT MARQUIS FLOW SWITCH
Applicant
MERIT MEDICAL SYSTEMS, INC.
parkmore business park west
galway, 

IE

ei

Applicant Contact mark mullaney
Correspondent
MERIT MEDICAL SYSTEMS, INC.
parkmore business park west
galway, 

IE

ei

Correspodent Contact mark mullaney
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 03/04/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No