K230957 is an FDA 510(k) clearance for the TriSalus TriNav® LV Infusion System. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Trisalus Life Sciences (Westminster, US). The FDA issued a Cleared decision on May 2, 2023, 28 days after receiving the submission on April 4, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K230957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2023 |
| Decision Date | May 02, 2023 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA - Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |