DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM— 510(k) K133399

Substantially Equivalent

Cardiovascular Systems Incorporated

FDA 510(k) clearance K133399 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, Substantially Equivalent on 2013-11-22. Applicant: Cardiovascular Systems Incorporated.

Clearance details

Applicant: Cardiovascular Systems Incorporated
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2013-11-06
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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.