510(k) Report

Devices descending from K140291

3 later devices reach Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+2K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+2K170385CORE M2 Vascular SystemVolcano Corporation20171—