Submission Details
| 510(k) Number | K231589 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Blood Tubing Lines for Hemodialysis AV06C-E
Jul 2023
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K231589 is an FDA 510(k) clearance for the Blood Tubing Lines for Hemodialysis AV06C-E, 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 review panel. Regulated under 21 CFR 876.5820.
Device Classification
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |
Manufacturer
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