K240257 is an FDA 510(k) clearance for the Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Bd (Tempe, US). The FDA issued a Cleared decision on February 29, 2024, 29 days after receiving the submission on January 31, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K240257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2024 |
| Decision Date | February 29, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTK - Filter, Intravascular, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3375 |