510(k) K193015
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2020
- Date Received
- October 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type