510(k) K233858
K233858 is an FDA 510(k) premarket notification submitted by Trisalus Life Sciences for the device "TriSalus TriGuideTM Guiding Catheter". The FDA issued a decision of Substantially Equivalent on December 27, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Trisalus Life Sciences has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2023
- Date Received
- December 5, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type