Device Classification Name |
Controller, Temperature, Cardiopulmonary Bypass
|
510(k) Number |
K071521 |
Device Name |
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
MARK A BUR |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
MARK A BUR |
Regulation Number | 870.4250
|
Classification Product Code |
|
Date Received | 06/04/2007 |
Decision Date | 11/21/2007 |
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
|
|
|