# K152765: Venatech Convertible Vena Cava Filter System

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Interventional Systems, Inc.
- Decided: Feb 26, 2016 after 155 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 K010485 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010485: Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave Filter, Bbraun (2001) Summary page 4.
- K063217: Venatech LP Brachial Introducer System (Antecubital), B.Braun Medical, Inc. (2007) Summary page 4.

## Most influential descendants
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K181202: Sentry IVC Filter (2018), 0 descendants of its own

## Indications for use
The VenaTech® Convertible™ Vena Cava Filter System is indicated for the prevention of recurrent pulmonary embolism via placement in the 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. When clinically indicated after implantation, the VenaTech Convertible filter can be converted to an open configuration to discontinue filtration according to the ‘Conversion Procedure’ in the Instructions for Use.

Source page: https://510kreport.com/device/K152765
Methodology: https://510kreport.com/methodology