Device Classification Name |
peripheral mechanical thrombectomy with aspiration
|
510(k) Number |
K133629 |
Device Name |
ANGIOJET ULTRA AVX THROMBECTOMY SET |
Applicant |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS,
MN
55433 -8003
|
|
Applicant Contact |
GEORGE LUCAS |
Correspondent |
POSSIS MEDICAL, INC. |
9055 EVERGREEN BLVD., N.W. |
MINNEAPOLIS,
MN
55433 -8003
|
|
Correspondent Contact |
GEORGE LUCAS |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 11/26/2013 |
Decision Date | 02/14/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|