Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K132777 |
Device Name |
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER |
Applicant |
EV3 INC |
3033 Campus Drive |
Plymouth,
MN
55441
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/05/2013 |
Decision Date | 09/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|