The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Impress Angiographic Catheter.
| Device ID | K191608 |
| 510k Number | K191608 |
| Device Name: | Impress Angiographic Catheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Luke Meidell |
| Correspondent | Luke Meidell Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-07-16 |