# K091077: Optease Vena Cava Filter and Retrieval Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp., A Johnson & Johnson Co.
- Decided: Feb 4, 2010 after 296 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K901502 (1990). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F, Cordis Corporation (2004) Summary page 1.
- K082305: G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits, C.R. Bard, Inc. (2008) Summary page 1.

## Most influential descendants
- K140286: Optease Vena Cava Filter and Optease Retrieval Cathteter (2014), 0 descendants of its own

## Recalls of this device
- Sep 27, 2013 · Class II · Z-0081-2014: Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in th
- Mar 29, 2013 · Class I · Z-1887-2013: Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

## Indications for use
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: * Pulmonary thromboembolism when anticoagulants are contrairndicated, * Failure of anticoagulant therapy for thromboembolic disease, * Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. * Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

Source page: https://510kreport.com/device/K091077
Methodology: https://510kreport.com/methodology