510(k) Report

Devices descending from K121273

3 later devices reach Visions PV .035 Ditital Ivus Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153094Visions PV .035 Digital IVUS CatheterVolcano Corporation201522
+2K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC20230—
+2K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC20190—