510(k) K143328
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip by
Volcano Atheromed, Inc.
— Product Code MCW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- November 20, 2014
- 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