510(k) K172386
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System by
Volcano Atheromed, Inc.
— Product Code MCW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2017
- Date Received
- August 8, 2017
- 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