# K120402: Crux Vena Cava Filter System

- Pathway: 510(k) (Traditional)
- Applicant: Crux Biomedical
- Decided: Jul 13, 2012 after 156 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: 6 generations back to K901502 (1990). 24 ancestors in all.
2 later devices descend 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)
- K081410: Option Vena Cava Filter, Rex Medical (2009) Summary page 2.

## Most influential descendants
- K122585: Crux Vena Cava Filter System (2013), 1 descendant of its own
- K150262: Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular (2015), 0 descendants of its own

## Indications for use
The Crux VCF System is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava (IVC) in the following situations: * Pulmonary thromboembolism when anticoagulants are contraindicated * Failure of anticoagulant therapy in thromboembolic diseases * 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 Crux VCF may be removed according to the instructions contained in the section "Optional Retrieval of the Crux VCF" in patients who no longer require a vena cava filter. Retrieval of the filter can be performed by femoral or jugular approach.

Source page: https://510kreport.com/device/K120402
Methodology: https://510kreport.com/methodology