510(k) Report

Devices descending from K964171

80 later devices reach Vasoview Balloon Dissection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981700Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc.199868—
+1K973046Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakGeneral Surgical Innovations199810—
+2K171939ALVUE Balloon Dilation SystemGlobus Medical, Inc.20180—
+2K090631Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie20099—
+2K06072340 L High Flow Insufflator F113W.O.M. World of Medicine AG200645—
+2K031891VirtuosaphTerumo Cardiovascular Systems Corp.20034—
+2K030512Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp.2003621
+2K023629Essex Dissection Cannula, Model SXD-1100, Essex Dissection Tip, Model SXD-1200Guidant Corporation, Cardiac Surgery20020—
+2K0142507MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114Guidant Corp.20021—
+3K1919307 mm Extended Length EndoscopeMaquet Cardiovascular, LLC20200—
+3K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd.20107—
+3K083194Virtuosaph (TM) Endoscopic Vein Harvesting Disposable System, Model MCVS550Terumo Cardiovascular Systems Corp.200931
+3K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG2007444
+3K062050Flexview SystemBoston Scientific20061—
+3K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation20057Class I
+3K041981Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…Guidant Corporation2004152
+4K230239AirSeal iFS System; AirSeal dV SolutionConmed Corporation20230—
+4K190303AirSealConmed Corporation20191—
+4K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+4K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC20161Class I
+4K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH201621—
+4K140008Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation201411
+4K132743Harvesting CannulaMaquet Cardiovascular, LLC20130—
+4K120151Nebulae INorthgate Technologies, Inc.2012222
+4K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation201132Class I
+4K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc.201135—
+4K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201062
+4K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC20104Class I
+4K092789Virtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp.201022
+4K091350Estech Hawkeye Introducer SystemsEndoscopic Technologies, Inc. D/B/A Estech20090—
+4K091733Vasoview 6 Pro Endoscopic Vessel Harvesting System, Model VH-2500Maquet Cardiovascular, LLC200921
+5K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3…Maquet Cardiovascular, LLC202501
+5K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Maquet Cardiovascular, LLC20242—
+5K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetConmed Corporation20210—
+5K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC20190—
+5K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—
+5K170784PneumoclearW.O.M. World of Medicine GmbH2017171
+5K161554Endoflator 40, Endoflator 50KARL STORZ Endoscopy-America, Inc.20171—
+5K160206VirtuoSaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corporation20160—
+5K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc.20152711
+5K140603Onepass Endoscopic Vessel Harvesting SysyetmSaphena Medical, Inc.201401
+5K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+5K132169Surgiquest Airseal IfsSurgiquest, Inc.20130—
+5K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation201231Class I
+5K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+5K120640Insuflow Synergy PortLexion Medical, LLC20125—
+5K121336Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…Surgiquest, Inc.20124—
+5K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc.20115—
+6K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.20250—
+6K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC20250—
+6K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation202501
+6K221995Gas InsufflatorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20230—
+6K201361PneumoclearW.O.M. World of Medicine GmbH202014—
+6K172516SurgiQuest AIRSEAL iFS SystemConmed Corporation20188—
+6K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+6K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+6K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+6K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc.201334
+7K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG20260—
+7K250388Endoflator +Karl Storz SE & CO. KG20251—
+7K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+7K193520EVA 15 InsufflatorPalliare, Ltd.20205—
+7K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard20171—
+8K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+8K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+8K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+8K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+8K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+8K230474EVA5 InsufflatorPalliare, Ltd.20231—
+8K202799EVA15Palliare, Ltd.20204—
+8K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+9K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+9K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.20260—
+9K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+9K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+9K222901EVA15 insufflatorPalliare, Ltd.20233—
+10K232902EVA15 insufflatorPalliare, Ltd.20240—