510(k) Report

Devices descending from K970080

53 later devices reach Arrow-Trerotola PTD Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041630Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated200530—
+1K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies20043—
+1K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+1K030504Akonya Eliminator Mechanical Thrombectomy Device, Model EL 10060060Idev Technologies, Inc.20031—
+1K031610Rex Medical Cleaner Rotational Thrombectomy SystemRex Medical2003131
+1K013473XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model #…Xtrak Medical, Inc.20021—
+2K071427Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems, Inc.2007282
+2K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.200728—
+2K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+2K052428Resolution Endovascular SystemOmnisonics Medical Technologies20052—
+2K041374Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060Idev Technologies, Inc.20050—
+2K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+2K021641XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc.200201
+3K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+3K111388Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemCardiovascular Systems, Inc.20110—
+3K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.2011201
+3K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+3K090521Diamondback 360 DBXCardiovascular Systems, Inc.2009242
+3K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc.200825—
+3K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc.200726—
+3K072800Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.20070—
+3K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+4K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+4K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+4K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+4K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+4K133999Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20140—
+4K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated20134Class I
+4K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc.20135—
+4K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20126—
+4K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+4K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+5K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+5K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+5K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+5K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+5K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+5K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+5K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20171—
+5K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+6K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+6K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+6K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+6K223891Cobra Catheter SystemEndovascular Engineering20232—
+6K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+6K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+6K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+6K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+7K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+7K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—
+8K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—