K240578 is an FDA 510(k) clearance for the VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 31, 2024, 152 days after receiving the submission on March 1, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K240578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2024 |
| Decision Date | July 31, 2024 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| 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 |