510(k) K193107
K193107 is an FDA 510(k) premarket notification submitted by Trisalus Life Sciences for the device "TriSalus Infusion System". The FDA issued a decision of Substantially Equivalent on December 3, 2019. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Trisalus Life Sciences has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2019
- Date Received
- November 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type