# K043509: Gunther Tulip Vena Cava Filter Set

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: May 5, 2005 after 136 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: 5 generations back to K901502 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000855: Gunther Tulip Vena Cava Mreye Filter Set, Cook, Inc. (2000) Summary page 1.
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set, Cook, Inc. (2003) Summary page 1.

## Indications for use
The GOnther TulipTM Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: * Pulmonary thromboembolism when antic-agulation therapy is contraindicated; * failure of anticoagulation therapy in thromboembolic diseases; * emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and * chronic, recurrent pulmonary embolism where anticoagulation therapy has failed or is contraindicated. The Gunther TulipTM Vena Cava FilterTM may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure The Gunther Tulip TM Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Gunther TulipTM Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach

Source page: https://510kreport.com/device/K043509
Methodology: https://510kreport.com/methodology