Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K024069 |
Device Name |
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 |
Applicant |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
RONALD W BENNETT |
Correspondent |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
RONALD W BENNETT |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/10/2002 |
Decision Date | 01/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|