Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K160107 |
Device Name |
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe |
Applicant |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
Dan W Lindsay |
Correspondent |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Dan W Lindsay |
Regulation Number | 870.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/19/2016 |
Decision Date | 07/29/2016 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|