K201866 is an FDA 510(k) clearance for the NovaLine Tubing Sets for Hemodialysis. This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 10, 2021, 246 days after receiving the submission on July 7, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K201866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | March 10, 2021 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK - Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |