# K190267: EZE SIT Valvulotome

- Pathway: 510(k) (Traditional)
- Applicant: Lemaitre Vascular
- Decided: Oct 30, 2019 after 264 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 K930011 (1993). 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)
- K930011: Uresil Valve Cutter with Interchangeable Heads, Uresil Corp. (1993) Summary page 4.

## Indications for use
The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.

Source page: https://510kreport.com/device/K190267
Methodology: https://510kreport.com/methodology