510(k) K221077
K221077 is an FDA 510(k) premarket notification submitted by Eximo Medical, Ltd. for the device "Auryon Atherectomy System". The FDA issued a decision of Substantially Equivalent on June 9, 2022. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Eximo Medical, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2022
- Date Received
- April 12, 2022
- 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