510(k) Report

Devices descending from K961999

28 later devices reach Schneider Guider Softip Guiding Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094048Percupro Messenger Balloon CatheterCardiosolutions, Inc.20110—
+1K980453Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc.19982620
+2K141981Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd.20152—
+2K132542Transgate Guide CatheterStryker Neurovascular20130—
+2K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp.2007212
+3K213589FUBUKI XF Neurovascular Long SheathAsahi Intecc Co., Ltd.20221—
+3K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+4K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd.20250—
+4K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+4K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+5K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+5K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+5K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+5K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+6K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+6K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+6K212047Pantheris SystemAvinger, Inc.20210—
+6K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+6K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+6K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+7K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+7K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+7K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+8K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+8K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+9K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+10K260244Auryon Atherectomy SystemEximo Medical20260—
+10K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401