K251442
- 510(k) number
- K251442
- Device name
- TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
- Applicant
- Ningbo Tianyi Medical Appliance Co., Ltd. CN
- Product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitat
- Decision date
- 2025-10-02
- Date received
- 2025-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251442.pdf
Official FDA record: K251442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.