510(k) K220109
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System by
Cardiovascular Systems, Inc.
— Product Code MCW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2022
- Date Received
- January 13, 2022
- 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