510(k) K231538
K231538 is an FDA 510(k) premarket notification submitted by Cardio Flow Inc., for the device "FreedomFlow Orbital Circumferential Atherectomy System". The FDA issued a decision of Substantially Equivalent on September 27, 2023. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Cardio Flow Inc., has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2023
- Date Received
- May 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type