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Valvulotome
FDA product code MGZ · Class 2 · Cardiovascular
48
Registered devices
131
Adverse events
6
Recalls
27
510(k) clearances
Devices with this code
Hydro LeMaitre Valvulotome — Lemaitre Vascular, Inc.Antegrade and Retrograde LeMills Valvulotome — Lemaitre Vascular, Inc.LimFlow Vector — Inari Medical, Inc.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCValvulotome 25cm, blade 2mm, w/ball — Geister Medizintechnik GmbHTru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCSCANLAN® In Situ Valvulotomes — SCANLAN INTERNATIONAL INCSCANLAN® In Situ Valvulotomes — SCANLAN INTERNATIONAL INCTru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCAntegrade LeMills Valvulotome — Lemaitre Vascular, Inc.Wexler Surgical, Inc. — WEXLER SURGICAL, INC.Hydro LeMaitre Valvulotome — Lemaitre Vascular, Inc.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCTru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCSCANLAN® In Situ Valvulotomes — SCANLAN INTERNATIONAL INCSCANLAN® In Situ Valvulotomes — SCANLAN INTERNATIONAL INCEze-Sit Valvulotome — Lemaitre Vascular, Inc.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCSCANLAN® In Situ Valvulotomes — SCANLAN INTERNATIONAL INCSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.HYDRO LeMaitre Valvulotome — Lemaitre Vascular, Inc.Expandable LeMaitre Valvulotome — Lemaitre Vascular, Inc.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | LimFlow, Inc. | Incorrect expiration date |
| 2023-07-13 | LeMaitre Vascular, Inc. | Burrs (molding flash) on the cutter may tear the harvested vien |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and theref |
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