Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K153598 |
Device Name |
Medtronic Bio-Medicus Adult Cannula Kit |
Applicant |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
JENNIFER TANG |
Correspondent |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
JENNIFER TANG |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/16/2015 |
Decision Date | 01/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|