510(k) Report

Devices descending from K143328

3 later devices reach 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+2K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+2K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—