Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K143083 |
Device Name |
Bio-Medicus Pediatric Cannula and Introducers |
Applicant |
MEDTRONIC, INC |
8200 CORAL ST NE |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
BRUCE BACKLUND |
Correspondent |
MEDTRONIC, INC |
8200 CORAL ST NE |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
BRUCE BACKLUND |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/27/2014 |
Decision Date | 03/25/2015 |
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
|
|
|