MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM— 510(k) K081944

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K081944 for MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM, Substantially Equivalent on 2008-08-14. Applicant: Cardio Systems, Inc..

Clearance details

Applicant: Cardio Systems, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2008-07-08
Decision date: 2008-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint 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.