FDA.reportPublic FDA data

510(k) K250105

Device
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
Applicant
Aveera Medical, Inc.
510(k) number
K250105
Product code
MGZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-03
Date received
2025-01-15
Regulation
870.4885
Classification name
Valvulotome
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christopher Chapek
Address
929 Calle Negocio Suite A San Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MGZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260188LimFlow VectorLimFlow, Inc.2026-03-18
K221902LimFlow VectorLimFlow, Inc.2022-12-21
K190267EZE SIT ValvulotomeLemaitre Vascular2019-10-30
K142660Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc.2014-10-17
K1400421.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.2014-04-10
K132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.2013-11-05
K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.2013-08-05
K111884OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.2011-07-29
K080178VALVULOTOME BY KOVENKoven Technology, Inc.2008-07-28
K022823VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520Geister Medizin Technik GmbH2004-07-01
K001734FOGARTY VALVULOTOME, MODEL 700091Edwards Lifesciences, LLC2001-03-26
K9807232.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)Vascutech, Inc.1999-02-12
K965137FOGARTY VALVULOTOME MODEL 700091Baxter Edwards1997-06-04
K946352LEMAITRE VALVULOTOME IIVascutech, Inc.1995-06-21
K925283VALVULOTOMEIntramed Laboratories, Inc.1994-02-10