510(k) Report

Devices descending from K072748

26 later devices reach Modification to: Diamondback 360 Orbital Atherectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090521Diamondback 360 DBXCardiovascular Systems, Inc.2009242
+1K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc.200825—
+2K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+2K111388Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemCardiovascular Systems, Inc.20110—
+2K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.2011201
+3K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+3K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+3K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+3K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+3K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+3K133999Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20140—
+3K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated20134Class I
+3K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc.20135—
+3K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20126—
+4K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+4K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+4K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+4K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+4K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+4K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+4K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20171—
+5K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+5K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+5K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+5K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+6K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—