Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K191608 |
Device Name |
Impress Angiographic Catheter |
Applicant |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Applicant Contact |
Luke Meidell |
Correspondent |
Merit Medical Systems, Inc. |
1600 West Merit Parkway |
South Jordan,
UT
84095
|
|
Correspondent Contact |
Luke Meidell |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 06/17/2019 |
Decision Date | 07/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|