FreedomFlow Orbital Circumferential Atherectomy System— 510(k) K231538

Substantially Equivalent

Cardio Flow Inc.,

FDA 510(k) clearance K231538 for FreedomFlow Orbital Circumferential Atherectomy System, Substantially Equivalent on 2023-09-27. Applicant: Cardio Flow Inc.,.

Clearance details

Applicant: Cardio Flow Inc.,
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2023-05-30
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blaine, 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.