# K233619: Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: May 20, 2024 after 189 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 K901625 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901625: Fogarty Arterial Embolectomy II Catheter, Baxter Healthcare Corp (1990) Summary page 5.
- K942457: Graft Thrombectomy Instruments, Intramed Laboratories, Inc. (1995) Summary page 5.

## Indications for use
The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts. The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non‐thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo‐femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.

Source page: https://510kreport.com/device/K233619
Methodology: https://510kreport.com/methodology