510(k) Report

Devices descending from K982329

5 later devices reach Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071660Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900Volcano Corporation20074—
+2K121273Visions PV .035 Ditital Ivus CatheterVolcano Corporation201233
+3K153094Visions PV .035 Digital IVUS CatheterVolcano Corporation201522
+4K230584Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC20230—
+4K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC20190—