Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K141295 |
Device Name |
MERIT HYDROPHILIC GUIDEWIRE |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
IRELAND
|
|
Applicant Contact |
MICHAEL O'SULLIVAN |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
IRELAND
|
|
Correspondent Contact |
MICHAEL O'SULLIVAN |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 05/19/2014 |
Decision Date | 12/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|