510(k) K214009
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2023
- Date Received
- November 5, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type