# K211610: Fogarty Occlusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 14, 2022 after 265 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K093911 (2010). 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)
- K152762: Fogarty Occlusion Catheter, Edwards Lifesciences, LLC (2015) Summary page 4.

## Indications for use
The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion. The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein. The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.

Source page: https://510kreport.com/device/K211610
Methodology: https://510kreport.com/methodology