Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K162214 |
Device Name |
Protek Solo 24 Fr Venous Cannula Set |
Applicant |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Applicant Contact |
GREG JOHNSON |
Correspondent |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Correspondent Contact |
GREG JOHNSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/08/2016 |
Decision Date | 11/30/2016 |
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
|
|
|