510(k) Report

Devices descending from K896466

15 later devices reach Swan-Ganz Thermodilution Ejection Fraction/Volume through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp199514—
+2K160084Swan Ganz CathetersEdwards Lifesciences, LLC201613Class I
+3K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…Bioptimal International Pte., Ltd.20260—
+3K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+3K233824Swan-Ganz catheterEdwards Lifesciences, LLC202401
+3K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+3K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC20221—
+3K193466Swan-Ganz CathetersEdwards Lifesciences, LLC20200—
+4K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+4K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+4K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—