# K023116: Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Oct 18, 2002 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit: named in the summary without a submission number
- (no number) Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator: named in the summary without a submission number
- (no number) Gunther Tulip Vena Cava MReye Filter set, Cook Incorporated: named in the summary without a submission number
- (no number) Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter: named in the summary without a submission number

## Most influential descendants
- K081410: Option Vena Cava Filter (2009), 6 descendants of its own
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), 5 descendants of its own
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K133243: Option Elite Vena Cava Filter System (2013), 2 descendants of its own
- K120402: Crux Vena Cava Filter System (2012), 2 descendants of its own

## Indications for use
The OptEaseTM is indicated for the prevention of recurrent pulmonary embolism via permanent, percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Source page: https://510kreport.com/device/K023116
Methodology: https://510kreport.com/methodology