K250723
- 510(k) number
- K250723
- Device name
- FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- Applicant
- Cardio Flow Inc., MN · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2025-04-25
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250723.pdf
Official FDA record: K250723
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.