Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series— 510(k) K220568

Name: FDA 510(k) clearance K220568
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Substantially Equivalent

Cardiovascualr Systems, Inc.

FDA 510(k) clearance K220568 for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series, Substantially Equivalent on 2022-04-27. Applicant: Cardiovascualr Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascualr Systems, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2022-02-28
Decision date: 2022-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MCW

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K260244 — Auryon Atherectomy System2026-04-10
K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)2025-04-25
K250385 — Turbo-Elite Laser Atherectomy Catheter2025-03-13
K242757 — Rotarex Atherectomy System2025-01-30
K242947 — FreedomFlow Orbital Circumferential Atherectomy System2024-11-05

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.