510(k) Report

Devices descending from K160084

13 later devices reach Swan Ganz Catheters through their predicates, nearest generation first.

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