510(k) Report

Devices descending from K150442

5 later devices reach Volcano Visions PV .018 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—
+1K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.20250—
+1K230928Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterVein 360, LLC20230—
+1K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+2K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—