Device Classification Name |
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
|
510(k) Number |
K083834 |
Device Name |
TERUMO PALL AL6X ARTERIAL FILTER |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
EILEEN DORSEY |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
EILEEN DORSEY |
Regulation Number | 870.4260
|
Classification Product Code |
|
Date Received | 12/23/2008 |
Decision Date | 04/17/2009 |
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
|
|
|