Device Classification Name |
catheter, intravascular occluding, temporary
|
510(k) Number |
K031357 |
Device Name |
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM |
Applicant |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS,
MN
55433 -8003
|
|
Applicant Contact |
MARK STENOIEN |
Correspondent |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS,
MN
55433 -8003
|
|
Correspondent Contact |
MARK STENOIEN |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 04/30/2003 |
Decision Date | 05/18/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|