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510(k) K924075

Device
DISPOSABLE OPTICAL VALVULOTOME
Applicant
ENDOVASCULAR, INC.
510(k) number
K924075
Product code
MGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-08
Date received
1992-08-12
Regulation
870.4885
Classification name
Valvulotome
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KAREN U SALINAS
Address
3180 Pullman St. Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MGZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260188LimFlow VectorLimFlow, Inc.2026-03-18
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
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

Legacy Summary#

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FDA Review#

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