# K240257: Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

- Pathway: 510(k) (Special)
- Applicant: Bd
- Decided: Feb 29, 2024 after 29 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: 11 generations back to K022236 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160866: Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit, C.R. Bard, Inc. (2016) Summary page 4.

## Indications for use
The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: -Pulmonary thromboembolism when anticoagulants are contraindicated -Failure of anticoagulant therapy for 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 Denali™ Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.

Source page: https://510kreport.com/device/K240257
Methodology: https://510kreport.com/methodology