# K121629: Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr

- Pathway: 510(k) (Traditional)
- Applicant: William Cook Europe Aps
- Decided: Jul 3, 2012 after 29 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: 6 generations back to K901502 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set, William Cook Europe Aps (2008) Summary page 2.
- K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter, William Cook Europe Aps (2009) Summary page 2.
- K121057: Cook Celect and Gunther Tulip Vena Cava Filter Sets, William Cook Europe Aps (2012) Summary page 2.

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

Source page: https://510kreport.com/device/K121629
Methodology: https://510kreport.com/methodology