510(k) K203365
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2021
- Date Received
- November 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Catheter, Ultrasound
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.