Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K103322 |
Device Name |
EVERCROSS 0.035 OTW PTA DILATION CATHETER |
Applicant |
EV3 INC |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Applicant Contact |
DAVID WORRELL, MS, RAC |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/12/2010 |
Decision Date | 12/06/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|