# K233819: Fogarty Venous Thrombectomy Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 22, 2024 after 173 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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) Preamendment Fogarty Venous Thrombectomy Catheters: named in the summary without a submission number

## Indications for use
Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Source page: https://510kreport.com/device/K233819
Methodology: https://510kreport.com/methodology