510(k) Report

Devices descending from K881088

117 later devices reach Addition of a Tip Guard to the Atherocath (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+7K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+7K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+7K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+7K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+7K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+7K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+7K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc.20160Class I
+7K160827Pantheris CatheterAvinger, Inc.20164—
+7K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+8K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+8K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+8K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—
+8K173862Pantheris SystemAvinger, Inc.20181—
+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