Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K823125 |
Device Name |
CAPIOX II |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 10/25/1982 |
Decision Date | 11/24/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|