510(k) Report

Devices descending from K901206

102 later devices reach Rotablator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260244Auryon Atherectomy SystemEximo Medical20260—
+9K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401