510(k) Report

Devices descending from K190634

4 later devices reach Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+1K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+1K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+2K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—