Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K062381 |
Device Name |
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR |
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 | 08/15/2006 |
Decision Date | 08/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|