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— 510(k) K242479
Substantially EquivalentNIKKISO CO., LTD.
FDA 510(k) clearance K242479 for 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, Substantially Equivalent on 2025-05-15. Applicant: NIKKISO CO., LTD.. Device class: 2.
Clearance details
- Applicant
- NIKKISO CO., LTD.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shibuya-Ku, JP
Recent devices under product code KOC
view all- 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)
- K231589 — Blood Tubing Lines for Hemodialysis AV06C-E
- K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
- K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
- K172238 — CAREline Airless Hemodialysis Blood Tubing Sets
More clearances from NIKKISO CO., LTD.
view all- K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- K152938 — DBB-06 Hemodialysis Delivery System
- K091978 — DBB-06 HEMODIALYSIS DELIVERY SYSTEM
- K082719 — NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
- K061519 — MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
Adverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.