# K152762: Fogarty Occlusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 23, 2015 after 60 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: 1 generation back to K093911 (2010). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093911: Fogarty Occlusion Catheter, Edwards Lifesciences, LLC (2010) Summary page 4.
- (no number) Fogarty Occlusion Catheter, Pre-amendment device: named in the summary without a submission number

## Most influential descendants
- K211610: Fogarty Occlusion Catheter (2022), 0 descendants of its own
- K160598: REBOA Balloon Catheter (2016), 0 descendants of its own

## Indications for use
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/K152762
Methodology: https://510kreport.com/methodology