K250836
- 510(k) number
- K250836
- Device name
- 14F Duo-Flow® Side X Side Double Lumen Catheter
- Applicant
- Medical Components, Inc. PA · US
- Product code
- MPB — Catheter, Hemodialysis, Non-Implanted
- Decision date
- 2025-08-12
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250836.pdf
Official FDA record: K250836
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.