# K093911: Fogarty Occlusion Catheter

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 21, 2010 after 30 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fogarty Occlusion Catheter, Pre-amendment Device: named in the summary without a submission number

## Most influential descendants
- K152762: Fogarty Occlusion Catheter (2015), 2 descendants of its own
- K211610: Fogarty Occlusion Catheter (2022), 0 descendants of its own
- K160598: REBOA Balloon Catheter (2016), 0 descendants of its own
- K132022: Lemaitre 8F Occlusion Catheter (2013), 0 descendants of its own

## Indications for use
The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion.

Source page: https://510kreport.com/device/K093911
Methodology: https://510kreport.com/methodology