510(k) K200374
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2020
- Date Received
- February 14, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guide, Wire, Catheter, Neurovasculature
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- NE
- Submission Type