K193107 is an FDA 510(k) clearance for the TriSalus 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 December 3, 2019, 25 days after receiving the submission on November 8, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K193107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2019 |
| Decision Date | December 03, 2019 |
| Days to Decision | 25 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 |