Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series— 510(k) K230514
Substantially EquivalentNIKKISO CO., LTD.
FDA 510(k) clearance K230514 for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series, Substantially Equivalent on 2023-06-16. Applicant: NIKKISO CO., LTD..
Clearance details
- Applicant
- NIKKISO CO., LTD.
- Product code
- Code KOC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shibuya-Ku, JP
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.