Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System— 510(k) K190634

Substantially Equivalent

Cardiovascular Systems, Inc.

FDA 510(k) clearance K190634 for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Substantially Equivalent on 2019-07-02. Applicant: Cardiovascular Systems, Inc..

Clearance details

Applicant: Cardiovascular Systems, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2019-03-12
Decision date: 2019-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Paul, MN, US

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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.