HEMOSTASIS VALVE


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K072556
Device Name HEMOSTASIS VALVE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Applicant Contact shirley hyink
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan, 
UT 
84095

Correspodent Contact shirley hyink
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 09/10/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No