510(k) K202835
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2020
- Date Received
- September 25, 2020
- Clearance Type
- Special
- 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