# K082305: G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 31, 2008 after 79 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: 5 generations back to K022236 (2002). 7 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080668: G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery Kits, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- K093659: Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5 (2010), 8 descendants of its own
- K101431: Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits (2010), 6 descendants of its own
- K130366: Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit (2013), 3 descendants of its own
- 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

## Indications for use
The G2 EXPRESS TM Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent 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. G2 EXPRESS TM Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Source page: https://510kreport.com/device/K082305
Methodology: https://510kreport.com/methodology