Device Classification Name |
Injector And Syringe, Angiographic
|
510(k) Number |
K163084 |
Device Name |
Merit Coronary Control Syringe |
Applicant |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
Cory Marsh |
Correspondent |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Cory Marsh |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 11/03/2016 |
Decision Date | 06/15/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|