510(k) Report

Devices descending from K140775

17 later devices reach Turbo-Elite Atherectomy Catheters, Turbo Tandem System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+1K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+1K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+2K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+2K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+2K212047Pantheris SystemAvinger, Inc.20210—
+2K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+2K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+2K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+3K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+3K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+3K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+4K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+4K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+5K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+6K260244Auryon Atherectomy SystemEximo Medical20260—
+6K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401