GUARDIAN HEMOSTASIS VALVE


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K073620
Device Name GUARDIAN HEMOSTASIS VALVE
Applicant
ZERUSA LIMITED
219-220 business innovation
centre nuig,
galway, 

IE

Applicant Contact ger brett
Correspondent
ZERUSA LIMITED
219-220 business innovation
centre nuig,
galway, 

IE

Correspodent Contact ger brett
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 12/26/2007
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No