510(k) Report

Devices descending from K091299

20 later devices reach Spectranetics Turbo-Tandem System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+1K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+2K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+2K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+2K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+2K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+3K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+3K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+3K212047Pantheris SystemAvinger, Inc.20210—
+3K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+3K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+3K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+4K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+4K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+4K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+5K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+5K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+6K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+7K260244Auryon Atherectomy SystemEximo Medical20260—
+7K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401