FreedomFlow Orbital Circumferential Atherectomy System— 510(k) K231538
Substantially EquivalentCardio Flow Inc.,
FDA 510(k) clearance K231538 for FreedomFlow Orbital Circumferential Atherectomy System, Substantially Equivalent on 2023-09-27. Applicant: Cardio Flow Inc.,. Device class: 2.
Clearance details
- Applicant
- Cardio Flow Inc.,
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Blaine, MN, US
Recent devices under product code MCW
view allMore clearances from Cardio Flow Inc.,
view allAdverse 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, through . 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.