Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K993772 |
Device Name |
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARRY A COURTNEY |
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARRY A COURTNEY |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 11/08/1999 |
Decision Date | 06/05/2000 |
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
|
|
|