# K052578: Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Nov 25, 2005 after 66 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022236 (2002). 3 ancestors in all.
21 later devices descend from it; 1 cites it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050558: Modification to:  Recovery Filter System, Model RF-210F, C.R. Bard, Inc. (2005) Summary page 2.

## Most influential descendants
- K073090: Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J (2008), 20 descendants of its own
- K080668: G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery Kits (2008), 12 descendants of its own
- K082305: G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits (2008), 11 descendants of its own
- 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

## Recalls of this device
- Dec 20, 2006 · Not classified · Z-0393-2007: This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.
- Dec 20, 2006 · Not classified · Z-0394-2007: This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.

## Indications for use
The G2 TM Filter System - Jugular/Subclavian Delivery Kit is 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.

Source page: https://510kreport.com/device/K052578
Methodology: https://510kreport.com/methodology