Device Classification Name |
filter, blood, cardiopulmonary bypass, arterial line
|
510(k) Number |
K943917 |
Device Name |
CAPIOX ARTERIAL FILTER |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
SANDI HARTKA |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
SANDI HARTKA |
Regulation Number | 870.4260
|
Classification Product Code |
|
Date Received | 08/11/1994 |
Decision Date | 07/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|