Product Code: MGZ FDA class 2 21 CFR 870.4885

Valvulotome

Cardiovascular

The valvulotome is a cardiovascular surgical instrument used to cut or incise venous valves within saphenous veins to render them incompetent, allowing the vein to be used as an in-situ arterial bypass conduit for vascular reconstruction. It is classified as FDA Class II under 21 CFR 870.4885 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MGZ and the device is not implanted. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MGZ
Device Class: FDA class 2
Regulation Number: 870.4885
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260188	LimFlow Vector	Mar 18, 2026	Substantially Equivalent	LimFlow, Inc.
K250105	Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)	Jul 03, 2025	Substantially Equivalent	Aveera Medical, Inc.
K221902	LimFlow Vector	Dec 21, 2022	Substantially Equivalent	LimFlow, Inc.
K190267	EZE SIT Valvulotome	Oct 30, 2019	Substantially Equivalent	Lemaitre Vascular
K142660	Antegrade LeMills Valvulotome	Oct 17, 2014	Substantially Equivalent	LeMaitre Vascular, Inc.
K140042	1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME	Apr 10, 2014	Substantially Equivalent	LeMaitre Vascular, Inc.
K132047	LEMILLS VALVULOTOME	Nov 05, 2013	Substantially Equivalent	LeMaitre Vascular, Inc.
K132190	EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME	Aug 05, 2013	Substantially Equivalent	LeMaitre Vascular, Inc.
K111884	OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME	Jul 29, 2011	Substantially Equivalent	LeMaitre Vascular, Inc.
K080178	VALVULOTOME BY KOVEN	Jul 28, 2008	Substantially Equivalent	Koven Technology, Inc.
K022823	VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520	Jul 01, 2004	Substantially Equivalent	Geister Medizin Technik GmbH
K001734	FOGARTY VALVULOTOME, MODEL 700091	Mar 26, 2001	Substantially Equivalent	Edwards Lifesciences, LLC
K980723	2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)	Feb 12, 1999	Substantially Equivalent	Vascutech, Inc.
K965137	FOGARTY VALVULOTOME MODEL 700091	Jun 04, 1997	Substantially Equivalent	Baxter Edwards
K946352	LEMAITRE VALVULOTOME II	Jun 21, 1995	Substantially Equivalent	Vascutech, Inc.
K925283	VALVULOTOME	Feb 10, 1994	Substantially Equivalent	Intramed Laboratories, Inc.
K932009	THE SAMUELS RETROGRAD VALVULOTOME	Sep 21, 1993	Substantially Equivalent	Vascutech, Inc.
K930011	URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS	May 26, 1993	Substantially Equivalent	Uresil Corp.
K924171	LEMAITRE RETROGRADE VALVULOTOME	Feb 16, 1993	Substantially Equivalent	Vascutech, Inc.
K924075	DISPOSABLE OPTICAL VALVULOTOME	Feb 08, 1993	Substantially Equivalent	Endovascular, Inc.
K914385	OPTICAL VALVULOTOME	Mar 02, 1992	Substantially Equivalent	Intramed Laboratories, Inc.
K911184	SCANLAN/TAHERI VALVULOTOME	Feb 18, 1992	Substantially Equivalent	Scanlan Intl., Inc.
K914457	DISPOSABLE OPTICAL VALVULOTOME	Feb 05, 1992	Substantially Equivalent	Nobles-Lai Engineering, Inc.
K911702	OLYMPUS RETRACTABLE VALVULOTOME	Dec 27, 1991	Substantially Equivalent	Olympus Corp.
K912636	ANNULUS VALVULOTOME	Oct 18, 1991	Substantially Equivalent	Cardio Source
K912635	ANNULUS DISPOSABLE VALVULOTOME	Oct 18, 1991	Substantially Equivalent	Cardio Source
K911100	MEHIGAN-PILLING PHLEBETOME TM	Jun 21, 1991	Substantially Equivalent	Pilling Co.