Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K180456 |
Device Name |
Bio-Medicus Adult Cannulae Kit |
Applicant |
Medtronic Inc. |
8200 Coral Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
Huda Yusuf |
Correspondent |
Medtronic Inc. |
8200 Coral Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
Huda Yusuf |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 02/20/2018 |
Decision Date | 03/22/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|