# K132022: Lemaitre 8F Occlusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Nov 6, 2013 after 128 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 2 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)

## Recalls of this device
- Jul 24, 2019 · Class II · Z-2448-2019: incorrect device size being listed on the impacted device packaging

## Indications for use
LeMaitre SF Occlusion Catheter is indicated for temporary vessel occlusion.

Source page: https://510kreport.com/device/K132022
Methodology: https://510kreport.com/methodology