# K233820: Fogarty Arterial Embolectomy Catheter with Gate Valve

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- 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 Arterial Embolectomy Catheter: named in the summary without a submission number

## Indications for use
The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.

Source page: https://510kreport.com/device/K233820
Methodology: https://510kreport.com/methodology