# K080178: Valvulotome by Koven

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Jul 28, 2008 after 186 days
- Product code: MGZ (Valvulotome)
- Device class: 2
- Regulation: 21 CFR 870.4885
- 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 K946352 (1995). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946352: Lemaitre Valvulotome II, Vascutech, Inc. (1995) Summary page 1.

## Most influential descendants
- K132190: Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome (2013), 4 descendants of its own
- K221902: LimFlow Vector (2022), 1 descendant of its own
- K260188: LimFlow Vector (2026), 0 descendants of its own
- K250105: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (2025), 0 descendants of its own
- K140042: 1.5MM Hydro Expandable Lemaitre Valvulotome (2014), 0 descendants of its own

## Indications for use
The Valvulotome by Koven is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.

Source page: https://510kreport.com/device/K080178
Methodology: https://510kreport.com/methodology