# K172557: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

- Pathway: 510(k) (Traditional)
- Applicant: William Cook Europe Aps
- Decided: Nov 20, 2017 after 88 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090140 (2009). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter, William Cook Europe Aps (2009) Summary page 5.

## Most influential descendants
- K211874: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (2021), 1 descendant of its own
- K233680: Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter (2024), 0 descendants of its own

## Recalls of this device
- Feb 25, 2019 · Class III · Z-1021-2019: Updates to the Instructions for Use.
- Feb 25, 2019 · Class III · Z-1022-2019: Updates to the Instructions for Use.
- Feb 25, 2019 · Class III · Z-1023-2019: Updates to the Instructions for Use.

## Indications for use
The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and • Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the “Optional Filter Retrieval” section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Source page: https://510kreport.com/device/K172557
Methodology: https://510kreport.com/methodology