Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K163575 |
Device Name |
Inqwire Diagnostic Guide Wire |
Applicant |
Merit Medical Systems, Inc. |
Parkmore Business Park West |
Galway,
IE
N-A
|
|
Applicant Contact |
Mark Mullaney |
Correspondent |
Merit Medical Systems, Inc. |
Parkmore Business Park West |
Galway,
IE
N-A
|
|
Correspondent Contact |
Michael O’Sullivan |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 12/19/2016 |
Decision Date | 03/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|