# K222254: Gunther Tulip Vena Cava Filter Retrieval Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 16, 2023 after 293 days
- Product code: MMX (Device, Percutaneous Retrieval)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K901502 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181757: Günther Tulip® Vena Cava Filter Retrieval Set, Cook Incorporated (2018) Summary page 4.

## Indications for use
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters 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/K222254
Methodology: https://510kreport.com/methodology