FDA 510(k) Applications for Medical Device Product Code: MGZ (Valvulotome)

FDA 510(k) Applications for Medical Device Product Code "MGZ"
(Valvulotome)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K250105	Aveera Medical, Inc.	Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)	07/03/2025
K965137	BAXTER EDWARDS	FOGARTY VALVULOTOME MODEL 700091	06/04/1997
K001734	EDWARDS LIFESCIENCES, LLC.	FOGARTY VALVULOTOME, MODEL 700091	03/26/2001
K022823	GEISTER MEDIZINTECHNIK GMBH	VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520	07/01/2004
K080178	KOVEN TECHNOLOGY, INC.	VALVULOTOME BY KOVEN	07/28/2008
K190267	LeMaitre Vascular	EZE SIT Valvulotome	10/30/2019
K140042	LEMAITRE VASCULAR, INC.	1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME	04/10/2014
K142660	LeMaitre Vascular, Inc.	Antegrade LeMills Valvulotome	10/17/2014
K132190	LEMAITRE VASCULAR, INC.	EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME	08/05/2013
K132047	LEMAITRE VASCULAR, INC.	LEMILLS VALVULOTOME	11/05/2013
K111884	LEMAITRE VASCULAR, INC.	OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME	07/29/2011
K221902	LimFlow, Inc.	LimFlow Vector	12/21/2022
K980723	VASCUTECH, INC.	2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)	02/12/1999