# K101431: Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 25, 2010 after 35 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: 7 generations back to K022236 (2002). 9 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093659: Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5, C.R. Bard, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K240257: Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (2024), 0 descendants of its own

## Indications for use
The ECLIPSE 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. ECLIPSE 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/K101431
Methodology: https://510kreport.com/methodology