# K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 31, 2003 after 86 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: 4 generations back to K901502 (1990). 10 ancestors in all.
31 later devices descend from it; 4 cite it directly.
4 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000855: Gunther Tulip Vena Cava Mreye Filter Set, Cook, Inc. (2000)
- K972511: Amplatz Goose Neck Snare Kit/ Catheter, Microvena Corp. (1998) Summary page 1.
- K022201: Radius Micro Snare, Radius Medical Technologies, Inc. (2003)

## Most influential descendants
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set (2008), 16 descendants of its own
- K112185: Foursnare Vascular Retrieval Snare (2011), 6 descendants of its own
- K081410: Option Vena Cava Filter (2009), 6 descendants of its own
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), 5 descendants of its own
- K162875: Sentry IVC filter (2017), 2 descendants of its own

## Indications for use
The Gunther Tulip 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 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 Gunther Tulip Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure. The Gunther Tulip Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Gunther Tulip 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/K032426
Methodology: https://510kreport.com/methodology