510(k) K201717
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2020
- Date Received
- June 23, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type