510(k) Report

Devices descending from K153094

2 later devices reach Visions PV .035 Digital IVUS Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC20230—
+1K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC20190—