# K193379: Fogarty Arterial Embolectomy Catheter,  Fogarty Biliary Balloon Probe

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 12, 2020 after 190 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (0 Class I)
- 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 no predicate by number.

## Recalls of this device
- Oct 6, 2022 · Class II · Z-0147-2023: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
- Oct 6, 2022 · Class II · Z-0146-2023: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

## Indications for use
Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended. Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.

Source page: https://510kreport.com/device/K193379
Methodology: https://510kreport.com/methodology