MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K030449
Device Name MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
Applicant
TERUMO CORP.
125 blue ball rd.
elkton, 
MD 
21921

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

Correspodent Contact garry a courtney
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 02/11/2003
Decision Date 03/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No