Valvulotome
FDA product code MGZ · Class II (moderate risk) · 21 CFR 870.4885 · Cardiovascular
27510(k) clearances
0PMA approvals
6recalls
Manufacturers
- LeMaitre Vascular, Inc. 6
- Vascutech, Inc. 4
- Cardio Source 2
- Intramed Laboratories, Inc. 2
- LimFlow, Inc. 2
- Pilling Co. 1
- Olympus Corp. 1
- Nobles-Lai Engineering, Inc. 1
- Scanlan Intl., Inc. 1
- Endovascular, Inc. 1
- Uresil Corp. 1
- Baxter Edwards 1
- Edwards Lifesciences, LLC 1
- Geister Medizin Technik GmbH 1
- Koven Technology, Inc. 1
- Aveera Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260188 | LimFlow VectorMGZ · Special | LimFlow, Inc. | 03/18/2026SE |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)MGZ · Traditional | Aveera Medical, Inc. | 07/03/2025SE |
| K221902 | LimFlow VectorMGZ · Traditional | LimFlow, Inc. | 12/21/2022SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | Lemaitre Vascular | 10/30/2019SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 04/10/2014SE |
| K132047 | Lemills ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 11/05/2013SE |
| K132190 | Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 08/05/2013SE |
| K111884 | Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 07/29/2011SE |
| K080178 | Valvulotome by KovenMGZ · Traditional | Koven Technology, Inc. | 07/28/2008SE |
| K022823 | Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520MGZ · Traditional | Geister Medizin Technik GmbH | 07/01/2004SE |
| K001734 | Fogarty Valvulotome, Model 700091MGZ · Traditional | Edwards Lifesciences, LLC | 03/26/2001SE |
| K980723 | 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)MGZ · Traditional | Vascutech, Inc. | 02/12/1999SE |
| K965137 | Fogarty Valvulotome Model 700091MGZ · Traditional | Baxter Edwards | 06/04/1997SE |
| K946352 | Lemaitre Valvulotome IIMGZ · Traditional | Vascutech, Inc. | 06/21/1995SE |
| K925283 | ValvulotomeMGZ · Traditional | Intramed Laboratories, Inc. | 02/10/1994SE |
| K932009 | The Samuels Retrograd ValvulotomeMGZ · Traditional | Vascutech, Inc. | 09/21/1993SE |
| K930011 | Uresil Valve Cutter with Interchangeable HeadsMGZ · Traditional | Uresil Corp. | 05/26/1993SE |
| K924171 | Lemaitre Retrograde ValvulotomeMGZ · Traditional | Vascutech, Inc. | 02/16/1993SE |
| K924075 | Disposable Optical ValvulotomeMGZ · Traditional | Endovascular, Inc. | 02/08/1993SE |
| K914385 | Optical ValvulotomeMGZ · Traditional | Intramed Laboratories, Inc. | 03/02/1992SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | Scanlan Intl., Inc. | 02/18/1992SE |
| K914457 | Disposable Optical ValvulotomeMGZ · Traditional | Nobles-Lai Engineering, Inc. | 02/05/1992SE |
| K911702 | Olympus Retractable ValvulotomeMGZ · Traditional | Olympus Corp. | 12/27/1991SE |
| K912636 | Annulus ValvulotomeMGZ · Traditional | Cardio Source | 10/18/1991SE |
| K912635 | Annulus Disposable ValvulotomeMGZ · Traditional | Cardio Source | 10/18/1991SE |
| K911100 | Mehigan-Pilling Phlebetome TMMGZ · Traditional | Pilling Co. | 06/21/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1218-2026 Class II | Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23Incorrect expiration date | LimFlow, Inc. | 12/05/2025Open, Classified |
| Z-2468-2023 Class II | The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to…Burrs (molding flash) on the cutter may tear the harvested vien | LeMaitre Vascular, Inc. | 07/13/2023Open, Classified |
| Z-2545-2016 Class II | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | LeMaitre Vascular, Inc. | 08/03/2016Terminated |
| Z-2544-2016 Class II | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | LeMaitre Vascular, Inc. | 08/03/2016Terminated |
| Z-2543-2016 Class II | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | LeMaitre Vascular, Inc. | 08/03/2016Terminated |
| Z-0536-2015 Class II | An external vein stripper is an extravascular device used to remove a section of a vein…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |