The following data is part of a premarket notification filed by Trisalus Life Sciences with the FDA for Trisalus Infusion System.
| Device ID | K193107 |
| 510k Number | K193107 |
| Device Name: | TriSalus Infusion System |
| Classification | Catheter, Continuous Flush |
| Applicant | TriSalus Life Sciences 6272 W. 91st Avenue Westminster, CO 80031 |
| Contact | Patrick Mccain |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2019-12-03 |