510(k) K232945
K232945 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. (dba MedComp) for the device "Trio-CT® Triple Lumen Catheter w/ Curved Extensions". The FDA issued a decision of Substantially Equivalent (kit) on November 16, 2023. The device falls under product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. (dba MedComp) has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 16, 2023
- Date Received
- September 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.