510(k) K242176
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) by
NIKKISO CO., LTD.
— Product Code KOC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2025
- Date Received
- July 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type