# K181202: Sentry IVC Filter

- Pathway: 510(k) (Special)
- Applicant: Novate Medical, Ltd.
- Decided: Jun 6, 2018 after 30 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: 8 generations back to K901502 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173236: Sentry IVC Filter, Novate Medical, Ltd. (2018) Summary page 4.

## 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/K181202
Methodology: https://510kreport.com/methodology