CAPIOX SX10 HARDSHELL RESEVOIR


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K991973
Device Name CAPIOX SX10 HARDSHELL RESEVOIR
Applicant
TERUMO MEDICAL CORP.
125 blue ball rd.
elkton, 
MD 
21921

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

Correspodent Contact garry a courtney
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 06/11/1999
Decision Date 09/03/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized