Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K130280 |
Device Name |
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR |
Applicant |
TERUMO Corporation |
125 Blue Ball Road |
Elkton,
MD
21921
|
|
Applicant Contact |
GARRY A COURTNEY, MBA, RAC |
Correspondent |
TERUMO Corporation |
125 Blue Ball Road |
Elkton,
MD
21921
|
|
Correspondent Contact |
GARRY A COURTNEY, MBA, RAC |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 02/05/2013 |
Decision Date | 03/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|