# 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

- Pathway: 510(k) (Traditional)
- Applicant: William Cook Europe Aps
- Decided: Jan 18, 2024 after 63 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: 3 generations back to K090140 (2009). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211875: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, William Cook Europe Aps (2021) Summary page 5.
- 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, William Cook Europe Aps (2021) Summary page 5.

## Indications for use
The Gunther 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 Gunther 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. The Celect Platinum 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 Celect Platinum 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/K233680
Methodology: https://510kreport.com/methodology