510(k) Report

Devices descending from K141495

14 later devices reach Truwave Disposable Pressure Transducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC201741
+1K142749TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC20151311
+2K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC201912
+2K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC20181—
+2K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC201674
+3K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+3K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+3K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC20220—
+3K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC201801
+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—