Panels › Cardiovascular › Product code MGZ · Class 2
Valvulotome
Regulation 870.4885
1510(k)s in 12 months (27 all time)
1recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in MGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| LeMaitre Vascular, Inc. | 6 | 4 |
| Vascutech, Inc. | 4 | 0 |
| LimFlow, Inc. | 2 | 1 |
| Cardio Source | 2 | 0 |
| Intramed Laboratories, Inc. | 2 | 0 |
| Aveera Medical, Inc. | 1 | 0 |
| Baxter Edwards | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| Endovascular, Inc. | 1 | 0 |
| Geister Medizin Technik GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2026 | LimFlow, Inc. Brand Name: LimFlow Vector
Product Name: LimFlow Vector
Model/Catalog Number: VT-US-23 Open, Classified |
MGZ | K221902 |
| Aug 28, 2023 | LeMaitre Vascular, Inc. The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm Open, Classified |
MGZ | None listed |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile
REF # 1010-00
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or Terminated |
MGZ | K140042 |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile
REF# 1009-00J
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly Terminated |
MGZ | K140042 |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile
REF # 1009-00
Product Usage:
The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising o Terminated |
MGZ | K140042 |
| Dec 16, 2014 | Instrumed International, Inc. An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Ins Terminated |
MGZ | None listed |
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