510(k) Report

Devices descending from K110389

20 later devices reach Stealth 360 Orbital Pad System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+1K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+1K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+1K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+1K133999Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20140—
+1K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated20134Class I
+1K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc.20135—
+1K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20126—
+1K111388Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemCardiovascular Systems, Inc.20110—
+2K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+2K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+2K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+2K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+2K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+2K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20171—
+3K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+3K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+3K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+3K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+4K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—