K233483
- 510(k) number
- K233483
- Device name
- FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
- Applicant
- Cardio Flow Inc., MN · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2024-02-15
- Date received
- 2023-10-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233483.pdf
Official FDA record: K233483
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.