# K121057: Cook Celect and Gunther Tulip Vena Cava Filter Sets

- Pathway: 510(k) (Special)
- Applicant: William Cook Europe Aps
- Decided: May 4, 2012 after 28 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: 1 generation back to K090140 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite 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 2.

## Most influential descendants
- K172584: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (2017), 0 descendants of its own
- K121629: Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr (2012), 0 descendants of its own

## Indications for use
The Guinther Tulip Vena Cava 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 Guinther Tulip Vena Cava Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Guinther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent PE. The Cook Celect 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 Cook Celect Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Guinther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.

Source page: https://510kreport.com/device/K121057
Methodology: https://510kreport.com/methodology