# K081138: Safeflo Vena Cava Filter

- Pathway: 510(k) (Traditional)
- Applicant: Rmt Medical Technilogies, Inc.
- Decided: May 7, 2009 after 381 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Simon Nitinol Filter: named in the summary without a submission number
- (no number) OptEase Permanent Vena Cava Filter: named in the summary without a submission number

## Indications for use
The SafeFlo® Vena Cava Filter set 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.

Source page: https://510kreport.com/device/K081138
Methodology: https://510kreport.com/methodology