K242176
- 510(k) number
- K242176
- Device name
- BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
- Applicant
- NIKKISO CO., LTD. JP
- Product code
- KOC — Accessories, Blood Circuit, Hemodialysis
- Decision date
- 2025-05-15
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242176.pdf
Official FDA record: K242176
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.