K250794 is an FDA 510(k) clearance for the InVera Infusion Device. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Invera Medical (Galway, IE). The FDA issued a Cleared decision on March 12, 2026, 363 days after receiving the submission on March 14, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K250794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 363 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 |