510(k) Report

Devices descending from K071226

21 later devices reach 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+2K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+2K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+3K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+3K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+3K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+3K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+4K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+4K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+4K212047Pantheris SystemAvinger, Inc.20210—
+4K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+4K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+4K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+5K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+5K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+5K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+6K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+6K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+7K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+8K260244Auryon Atherectomy SystemEximo Medical20260—
+8K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401