Device Classification Name |
introducer, catheter
|
510(k) Number |
K011085 |
Device Name |
GUIDEWIRE INTRODUCER SAFETY NEEDLE |
Applicant |
MEDAMICUS, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
DENNIS S MADISON |
Correspondent |
MEDAMICUS, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
DENNIS S MADISON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/10/2001 |
Decision Date | 07/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|