# K093659: Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 14, 2010 after 50 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 K022236 (2002). 8 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082305: G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K102511: Meridan Filter System- Jungular/Subeclavian Delivery Kit (2011), 1 descendant of its own

## Indications for use
The ECLIPSETh 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 thramboembolism 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. • ECLIPSETm Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Source page: https://510kreport.com/device/K093659
Methodology: https://510kreport.com/methodology