BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
FDA 510(k) clearance K242479 · decided 2025-05-15
Clearance details
- K-number
- K242479
- Device name
- BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
- Applicant
- NIKKISO CO., LTD.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-21
- Decision date
- 2025-05-15
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- KOC
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shibuya-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.