510(k) K133243 ยท DTK Filter, Intravascular, Cardiovascular
OPTION ELITE VENA CAVA FILTER SYSTEM
| Applicant | Rex Medical, L.P., Great Neck NY, US |
| Decision | Substantially Equivalent, Dec 17, 2013 |
| Received | Oct 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2025 | Argon Medical Devices, Inc Option"ELITE Vena Cava Filter System REF 352506070E
UDI-DI code: 00886333217151
The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placemen Open, Classified |
DTK | None listed |
| Jul 27, 2023 | Argon Medical Devices, Inc Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 Open, Classified |
DTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.