K242947
- 510(k) number
- K242947
- Device name
- FreedomFlow Orbital Circumferential Atherectomy System
- Applicant
- Cardio Flow Inc., MN · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2024-11-05
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242947.pdf
Official FDA record: K242947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.