# K112497: Meridian Filter System - Femoral Delivery Kit

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 24, 2011 after 56 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: 9 generations back to K022236 (2002). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K102511: Meridan Filter System- Jungular/Subeclavian Delivery Kit, C.R. Bard, Inc. (2011) Summary page 1.

## Indications for use
The MERIDIAN TM Filter System - Femoral 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. MERIDIAN 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/K112497
Methodology: https://510kreport.com/methodology