# K161218: Gianturco-Roehm Bird’s Nest Vena Cava Filter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 22, 2016 after 84 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: 1 generation back to P850049 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P850049: Cook Bird's Nest Vena Cava Filter, Cook, Inc. (1989) Summary page 4.
- K073528: Vena Cava Filter, Cook Incorporated (2008) Summary page 4.

## Indications for use
The Gianturco-Roehm Bird’s Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: 1. Pulmonary thromboembolism when anticoagulants are contraindicated; 2. Failure of anticoagulant therapy in thromboembolic diseases; 3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; 4. Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Source page: https://510kreport.com/device/K161218
Methodology: https://510kreport.com/methodology