K143405 is an FDA 510(k) clearance for the Option (TM) ELITE Vena Cava Filter 100cm System. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Rex Medical, L.P. (Conshohocken, US). The FDA issued a Cleared decision on April 16, 2015, 139 days after receiving the submission on November 28, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K143405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2014 |
| Decision Date | April 16, 2015 |
| Days to Decision | 139 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 |