K251341
- 510(k) number
- K251341
- Device name
- VITAL Tubing Sets for Hemodialysis
- Applicant
- Vital Healthcare Sdn. Bhd. MY
- Product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitat
- Decision date
- 2026-01-16
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251341.pdf
Official FDA record: K251341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.