Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K034058 |
Device Name |
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 |
Applicant |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
PREETI JAIN |
Correspondent |
MEDTRONIC VASCULAR |
7611 NORTHLAND DR. |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
PREETI JAIN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/30/2003 |
Decision Date | 01/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|