Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K133236 |
Device Name |
TANDEMHEART FEMORAL VENOUS CANNULA SET |
Applicant |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
Pgh,
PA
15238
|
|
Applicant Contact |
Greg Johnson |
Correspondent |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
Pgh,
PA
15238
|
|
Correspondent Contact |
Greg Johnson |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/21/2013 |
Decision Date | 01/29/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|