Blood Tubing Lines for Hemodialysis AV06C-E— 510(k) K231589

Substantially Equivalent

NIKKISO CO., LTD.

FDA 510(k) clearance K231589 for Blood Tubing Lines for Hemodialysis AV06C-E, Substantially Equivalent on 2023-07-28. Applicant: NIKKISO CO., LTD..

Clearance details

Applicant: NIKKISO CO., LTD.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 2023-06-01
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shibuya-Ku, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.