# K240078: Fogarty Thru-Lumen Embolectomy Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 28, 2024 after 230 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
Longest line of descent: 1 generation back to K892410 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 5.

## Indications for use
The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

Source page: https://510kreport.com/device/K240078
Methodology: https://510kreport.com/methodology