510(k) · Cleared
ClearedEZE SIT Valvulotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lemaitre Vascular · MGZ Valvulotome
Cleared on Oct 30, 2019 as substantially equivalent to K930011 (Uresil Corp., 1993) after a 264-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 30, 2019
- Review
- 264 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930011 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930011 Uresil Valve Cutter with Interchangeable HeadsUresil Corp. · 1993
- This deviceK190267 EZE SIT ValvulotomeLemaitre Vascular · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930011 | Uresil Valve Cutter with Interchangeable Heads | Uresil Corp. | 1993 | — |
| 0 (this device) | K190267 | EZE SIT Valvulotome | Lemaitre Vascular | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MGZ device
- #1 K260188 LimFlow Vectorscore 11.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930011 | Uresil Valve Cutter with Interchangeable HeadsSummary page 4…o prior submissions have been made for the changes detailed in this traditional 510(k). II. PREDICATE DEVICE Tru-Incise Valvulotome (K930011) This predicate device has not been subject to a design- related recall… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K930011.
How does its category compare?
All MGZ devicesMGZ Valvulotome: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGZ
Too few MGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGZ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGZ
8in 2025
MAUDE reports naming product code MGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190267: EZE SIT Valvulotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190267
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026