# K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E)

- Pathway: 510(k) (Special)
- Applicant: Argon Medical Devices, Inc.
- Decided: Sep 10, 2024 after 7 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K901502 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133243: Option Elite Vena Cava Filter System, Rex Medical, L.P. (2013) Summary page 5.
- K143405: Option (TM) ELITE Vena Cava Filter 100cm System, Rex Medical, L.P. (2015) Summary page 5.

## Indications for use
The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled “Optional Procedure for Filter Retrieval” in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach. The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled “Optional Procedure for Filter Retrieval” in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

Source page: https://510kreport.com/device/K242612
Methodology: https://510kreport.com/methodology