510(k) Report

Devices descending from K152829

4 later devices reach Visions PV.014P RX Digital IVUS Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+1K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+1K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.20201—
+2K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.20230—