# K072240: Gunther Tulip Vena Cava Filter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Nov 8, 2007 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Gunther Tulip Vena Cava Filter: named in the summary without a submission number

## Indications for use
The proposed Giinther TulipTM Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via, placement in the vena cava in the following situations: * Pulmonary thromboembolism when anticoagulant therapy is contraindicated; * Failure of anticoagulant therapy in thromboembolic diseases; * Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and * chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The Gtnther TulipTM Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure. Retrieval Set The Gtinther TulipTM Vena Cava Filter Retrieval Filter Set has been designed for retrieval of an implanted Ginther TulipTM Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by the jugular approach.

Source page: https://510kreport.com/device/K072240
Methodology: https://510kreport.com/methodology