Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K071572 |
Device Name |
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER |
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
|
|
Correspondent Contact |
GARRY A COURTNEY |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 06/08/2007 |
Decision Date | 07/23/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|