# K140042: 1.5MM Hydro Expandable Lemaitre Valvulotome

- Pathway: 510(k) (Traditional)
- Applicant: LeMaitre Vascular, Inc.
- Decided: Apr 10, 2014 after 92 days
- Product code: MGZ (Valvulotome)
- Device class: 2
- Regulation: 21 CFR 870.4885
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946352 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome, LeMaitre Vascular, Inc. (2013) Summary page 2.
- K980732: 3M Cdi Quick-Cells with Heparin Treatment, 3M Healthcare (1998) Summary page 2.

## Recalls of this device
- Aug 3, 2016 · Class II · Z-2544-2016: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
- Aug 3, 2016 · Class II · Z-2543-2016: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
- Aug 3, 2016 · Class II · Z-2545-2016: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

## Indications for use
It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.

Source page: https://510kreport.com/device/K140042
Methodology: https://510kreport.com/methodology