DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

About This 510(k) Submission

K220109 is an FDA 510(k) clearance for the DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardiovascular Systems, Inc. (St Paul, US). The FDA issued a Cleared decision on March 1, 2022, 47 days after receiving the submission on January 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.