# K143405: Option (TM) ELITE Vena Cava Filter 100cm System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical, L.P.
- Decided: Apr 16, 2015 after 139 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: 7 generations back to K901502 (1990). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E) (2024), 0 descendants of its own

## Indications for use
The Option(TM) ELITE Vena Cava Filter 100cm System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - Failure of anticoagulant therapy in thromboembolic diseases; - Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced; - Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach

Source page: https://510kreport.com/device/K143405
Methodology: https://510kreport.com/methodology