510(k) Report

Devices descending from K143701

10 later devices reach Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+1K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+1K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+1K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+1K152829Visions PV.014P RX Digital IVUS CatheterVolcano Corporation201541
+2K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+2K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+2K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.20230—
+2K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.20201—
+2K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I