510(k) Report

Devices descending from K894168

14 later devices reach Swan-Ganz Therm Cath SM Heart Amc Throm 93A102H5F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160084Swan Ganz CathetersEdwards Lifesciences, LLC201613Class I
+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—
+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—
+4K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+4K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+5K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+5K253034HemoSphere Stream ModuleEdwards Lifesciences20250—