# K162875: Sentry IVC filter

- Pathway: 510(k) (Traditional)
- Applicant: Novate Medical, Ltd.
- Decided: Feb 17, 2017 after 126 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). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 29 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 4.
- K152765: Venatech Convertible Vena Cava Filter System, B. Braun Interventional Systems, Inc. (2016) Summary page 4.

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

## Indications for use
The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, 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.

Source page: https://510kreport.com/device/K162875
Methodology: https://510kreport.com/methodology