Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K201595 |
Device Name |
Merit Hydrophilic Guide Wire |
Applicant |
Merit Medical Systems, Inc. |
Parkmore Business Park West |
Galway,
IE
h91 w274
|
|
Applicant Contact |
Mark Mullaney |
Correspondent |
Merit Medical Systems, Inc. |
Parkmore Business Park West |
Galway,
IE
H91 W274
|
|
Correspondent Contact |
Michael O'Sullivan |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 06/12/2020 |
Decision Date | 10/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|