# K020316: Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Mar 20, 2002 after 49 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K914007 (1991). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000062: Cordis Trapease Permanent Vena Cava Filter and Introduction Kit, Cordis Corp. (2000) Summary page 4.
- K003964: Trapease Permanent Vena Filter and Introduction Kit, Models 466-P306A and 466-P306B, Cordis Corp. (2001) Summary page 4.
- K010083: Trapease Permanent Vena Cava Filter and Introduction Kit, Model 466-P306A, Cordis Corp. (2001) Summary page 4.
- K992347: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands, Cordis Corp. (1999) Summary page 4.
- K914007: Cordis 5.2 French Super Torque Plus Cardio Cath, Cordis Corp. (1991) Summary page 4.
- K983023: Modification to Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1998) Summary page 4.
- K984500: Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1998) Summary page 4.

## Most influential descendants
- 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
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K091077: Optease Vena Cava Filter and Retrieval Catheter (2010), 1 descendant of its own
- K181202: Sentry IVC Filter (2018), 0 descendants of its own

## Indications for use
The Cordis TrapEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via 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. The VisEase 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/K020316
Methodology: https://510kreport.com/methodology
