K231538
- 510(k) number
- K231538
- Device name
- FreedomFlow Orbital Circumferential Atherectomy System
- Applicant
- Cardio Flow Inc., MN · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2023-09-27
- Date received
- 2023-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231538.pdf
Official FDA record: K231538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.