510(k) Report

Devices descending from K182397

3 later devices reach Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+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—