K231589 is an FDA 510(k) clearance for the Blood Tubing Lines for Hemodialysis AV06C-E. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by NIKKISO CO., LTD. (Shibuya-Ku, JP). The FDA issued a Cleared decision on July 28, 2023, 57 days after receiving the submission on June 1, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K231589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOC - Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |