510(k) Report

Devices descending from K925638

16 later devices reach Phoenix Disposable Pressure Transducer #73-600 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141495Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC201414—
+1K974241Scimed Informer Pressure Wire SystemScimed Life Systems, Inc.19980—
+2K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC201741
+2K142749TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC20151311
+3K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC201912
+3K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC20181—
+3K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC201674
+4K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+4K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+4K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC20220—
+4K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC201801
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—