K232945
- 510(k) number
- K232945
- Device name
- Trio-CT® Triple Lumen Catheter w/ Curved Extensions
- Applicant
- Medical Components, Inc. (dba MedComp) PA · US
- Product code
- NIE — Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Decision date
- 2023-11-16
- Date received
- 2023-09-20
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232945.pdf
Official FDA record: K232945
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.