Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K093286 |
Device Name |
POWERCROSS .018 OTW PTA DILATION CATHETER |
Applicant |
EV3 INC |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Applicant Contact |
SARA BAKKER |
Correspondent |
EV3 INC |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Correspondent Contact |
SARA BAKKER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/20/2009 |
Decision Date | 11/13/2009 |
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
|
|
|