Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K082425 |
Device Name |
TANDEMHEART TRANSSEPTAL CANNULA- EF 72 |
Applicant |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Applicant Contact |
ROBERT BOLLINGER |
Correspondent |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Correspondent Contact |
ROBERT BOLLINGER |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/22/2008 |
Decision Date | 09/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|