# K130366: Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 15, 2013 after 91 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K022236 (2002). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101431: Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits, C.R. Bard, Inc. (2010) Summary page 1.

## Most influential descendants
- K143208: Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit (2014), 2 descendants of its own
- K160866: Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit (2016), 1 descendant of its own
- K240257: Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (2024), 0 descendants of its own

## Recalls of this device
- Feb 9, 2016 · Class II · Z-1069-2016: Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
- Feb 9, 2016 · Class II · Z-1068-2016: Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
- Mar 13, 2015 · Class II · Z-0737-2016: IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.

## Indications for use
The DENALI® Filter System - Femoral and Jugular/Subclavian Delivery Kits are 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. 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/K130366
Methodology: https://510kreport.com/methodology