K242612 is an FDA 510(k) clearance for the Option ELITE Vena Cava Filter System (352506070E 352506100E). This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on September 10, 2024, 7 days after receiving the submission on September 3, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K242612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | September 10, 2024 |
| Days to Decision | 7 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 |