510(k) Report

Devices descending from K233668

2 later devices reach Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260244Auryon Atherectomy SystemEximo Medical20260—
+1K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401