The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Impress Angiographic Catheter With Hydrophilic Coating.
| Device ID | K093004 |
| 510k Number | K093004 |
| Device Name: | IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-02-12 |
| Summary: | summary |