Cleared Special

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

K210586 · Cardiovascular Systems, Inc. · Cardiovascular
Sep 2021
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K210586 is an FDA 510(k) clearance for the Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth 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 September 14, 2021, 200 days after receiving the submission on February 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K210586 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2021
Decision Date September 14, 2021
Days to Decision 200 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MCW — Catheter, Peripheral, Atherectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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