Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K160643 |
Device Name |
ENROUTE 0.014 Guidewire |
Applicant |
LAKE REGION MEDICAL |
PARKMORE W BUSINESS PARK |
GALWAY,
IE
G07001
|
|
Applicant Contact |
MICHAEL DUNNING |
Correspondent |
LAKE REGION MEDICAL |
PARKMORE W BUSINESS PARK |
GALWAY,
IE
G07001
|
|
Correspondent Contact |
MICHAEL DUNNING |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/07/2016 |
Decision Date | 10/18/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|