510(k) Report

Devices descending from K934742

28 later devices reach Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160084Swan Ganz CathetersEdwards Lifesciences, LLC201613Class I
+1K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312—
+1K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp199514—
+2K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…Bioptimal International Pte., Ltd.20260—
+2K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+2K233824Swan-Ganz catheterEdwards Lifesciences, LLC202401
+2K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+2K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC20221—
+2K193466Swan-Ganz CathetersEdwards Lifesciences, LLC20200—
+2K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.200311—
+3K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+3K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+3K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+3K131765Ecom Endotracheal Cardiac Output Monitor SystemConmed Corporation20131—
+3K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.20108—
+4K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+4K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+4K172196ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc.20170—
+4K133530Nuvasive Emg Endotracheal TubeNu Vasive, Incorporated20140—
+4K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc.20121Class I
+4K110989Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.2011410
+5K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+5K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube…Medtronic Xomed, Inc.20260—
+5K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+5K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube…Inomed Medizintechnik GmbH20250—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K130806Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc.20130—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302