FDA.reportPublic FDA data

510(k) K001734

Device
FOGARTY VALVULOTOME, MODEL 700091
Applicant
Edwards Lifesciences, LLC
510(k) number
K001734
Product code
MGZ
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-26
Date received
2000-06-07
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
N

Applicant Contact#

Contact
DIANE PETERSON
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MGZ#

510(k), Device, Applicant table
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K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.2025-07-03
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
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