MGZ · Valvulotome
Cardiovascular · 21 CFR 870.4885 · Class 2
Overview
| Product Code | MGZ |
|---|---|
| Device Name | Valvulotome |
| Regulation | 21 CFR 870.4885 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An external vein stripper is an extravascular device used to remove a section of a vein.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260188 | LimFlow Vector | LimFlow, Inc. | Mar 18, 2026 | SESE |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | Jul 3, 2025 | SESE |
| K221902 | LimFlow Vector | LimFlow, Inc. | Dec 21, 2022 | SESE |
| K190267 | EZE SIT Valvulotome | Lemaitre Vascular | Oct 30, 2019 | SESE |
| K142660 | Antegrade LeMills Valvulotome | LeMaitre Vascular, Inc. | Oct 17, 2014 | SESE |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Apr 10, 2014 | SESE |
| K132047 | LEMILLS VALVULOTOME | LeMaitre Vascular, Inc. | Nov 5, 2013 | SESE |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Aug 5, 2013 | SESE |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Jul 29, 2011 | SESE |
| K080178 | VALVULOTOME BY KOVEN | Koven Technology, Inc. | Jul 28, 2008 | SESE |
| K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | Geister Medizin Technik GmbH | Jul 1, 2004 | SESE |
| K001734 | FOGARTY VALVULOTOME, MODEL 700091 | Edwards Lifesciences, LLC | Mar 26, 2001 | SESE |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Vascutech, Inc. | Feb 12, 1999 | SESE |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Baxter Edwards | Jun 4, 1997 | SESE |
| K946352 | LEMAITRE VALVULOTOME II | Vascutech, Inc. | Jun 21, 1995 | SESE |
| K925283 | VALVULOTOME | Intramed Laboratories, Inc. | Feb 10, 1994 | SESE |
| K932009 | THE SAMUELS RETROGRAD VALVULOTOME | Vascutech, Inc. | Sep 21, 1993 | SESE |
| K930011 | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS | Uresil Corp. | May 26, 1993 | SESE |
| K924171 | LEMAITRE RETROGRADE VALVULOTOME | Vascutech, Inc. | Feb 16, 1993 | SESE |
| K924075 | DISPOSABLE OPTICAL VALVULOTOME | Endovascular, Inc. | Feb 8, 1993 | SESE |
Top Applicants
- LeMaitre Vascular, Inc. — 5 clearances
- Vascutech, Inc. — 4 clearances
- LimFlow, Inc. — 2 clearances
- Intramed Laboratories, Inc. — 2 clearances
- Cardio Source — 2 clearances
