Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K141118 |
Device Name |
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER |
Applicant |
EV3 INC |
3033 Campus Drive |
Suite N550 |
Plymouth,
MN
55441
|
|
Applicant Contact |
LAURA J LIND |
Correspondent |
EV3 INC |
3033 Campus Drive |
Suite N550 |
Plymouth,
MN
55441
|
|
Correspondent Contact |
LAURA J LIND |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/30/2014 |
Decision Date | 07/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|