CAPIOX CIRCUIT CONNECTORS


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K073474
Device Name CAPIOX CIRCUIT CONNECTORS
Applicant
TERUMO CORP.
125 blue ball rd.
elkton, 
MD 
21921

Applicant Contact garry courtney
Correspondent
TERUMO CORP.
125 blue ball rd.
elkton, 
MD 
21921

Correspodent Contact garry courtney
Regulation Number 870.4290
Classification Product Code
DTL  
Date Received 12/11/2007
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No