Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K042194 |
Device Name |
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
LYNN JENSEN |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
LYNN JENSEN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/12/2004 |
Decision Date | 09/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|