Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K010443 |
Device Name |
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARRY A COURTNEY |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARRY A COURTNEY |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 02/14/2001 |
Decision Date | 12/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|