Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4885](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4885) → MGZ — Valvulotome # MGZ · Valvulotome _Cardiovascular · 21 CFR 870.4885 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ ## Overview - **Product Code:** MGZ - **Device Name:** Valvulotome - **Regulation:** [21 CFR 870.4885](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4885) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K260188.md) | LimFlow Vector | LimFlow, Inc. | Mar 18, 2026 | SESE | | [K250105](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K250105.md) | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | Jul 3, 2025 | SESE | | [K221902](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K221902.md) | LimFlow Vector | LimFlow, Inc. | Dec 21, 2022 | SESE | | [K190267](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K190267.md) | EZE SIT Valvulotome | Lemaitre Vascular | Oct 30, 2019 | SESE | | [K142660](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K142660.md) | Antegrade LeMills Valvulotome | LeMaitre Vascular, Inc. | Oct 17, 2014 | SESE | | [K140042](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K140042.md) | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Apr 10, 2014 | SESE | | [K132047](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K132047.md) | LEMILLS VALVULOTOME | LeMaitre Vascular, Inc. | Nov 5, 2013 | SESE | | [K132190](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K132190.md) | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Aug 5, 2013 | SESE | | [K111884](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K111884.md) | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | Jul 29, 2011 | SESE | | [K080178](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K080178.md) | VALVULOTOME BY KOVEN | Koven Technology, Inc. | Jul 28, 2008 | SESE | | [K022823](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K022823.md) | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | Geister Medizin Technik GmbH | Jul 1, 2004 | SESE | | [K001734](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K001734.md) | FOGARTY VALVULOTOME, MODEL 700091 | Edwards Lifesciences, LLC | Mar 26, 2001 | SESE | | [K980723](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K980723.md) | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Vascutech, Inc. | Feb 12, 1999 | SESE | | [K965137](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K965137.md) | FOGARTY VALVULOTOME MODEL 700091 | Baxter Edwards | Jun 4, 1997 | SESE | | [K946352](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K946352.md) | LEMAITRE VALVULOTOME II | Vascutech, Inc. | Jun 21, 1995 | SESE | | [K925283](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K925283.md) | VALVULOTOME | Intramed Laboratories, Inc. | Feb 10, 1994 | SESE | | [K932009](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K932009.md) | THE SAMUELS RETROGRAD VALVULOTOME | Vascutech, Inc. | Sep 21, 1993 | SESE | | [K930011](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K930011.md) | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS | Uresil Corp. | May 26, 1993 | SESE | | [K924171](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K924171.md) | LEMAITRE RETROGRADE VALVULOTOME | Vascutech, Inc. | Feb 16, 1993 | SESE | | [K924075](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K924075.md) | DISPOSABLE OPTICAL VALVULOTOME | Endovascular, Inc. | Feb 8, 1993 | SESE | ## Top Applicants - LeMaitre Vascular, Inc. — 5 clearances - Vascutech, Inc. — 4 clearances - Cardio Source — 2 clearances - Intramed Laboratories, Inc. — 2 clearances - LimFlow, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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