Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K153140 |
Device Name |
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL ROAD |
ELKTON,
MD
21921
|
|
Applicant Contact |
JOSHUA P. EWING |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL ROAD |
ELKTON,
MD
21921
|
|
Correspondent Contact |
JOSHUA P. EWING |
Regulation Number | 870.4350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/30/2015 |
Decision Date | 12/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|