# K073528: Vena Cava Filter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Feb 27, 2008 after 72 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gianturco-Roehm Bird's Nest® Vena Cava Filter: named in the summary without a submission number

## Most influential descendants
- K161218: Gianturco-Roehm Bird’s Nest Vena Cava Filter (2016), 0 descendants of its own

## 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/K073528
Methodology: https://510kreport.com/methodology