510(k) Report

Devices descending from K133641

5 later devices reach Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core Mobile 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—
+1K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation20150—
+1K140291Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound…Volcano Corporation20143—
+2K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+2K170385CORE M2 Vascular SystemVolcano Corporation20171—