K202796 is an FDA 510(k) clearance for the SANSIN 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 Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on September 6, 2021, 348 days after receiving the submission on September 23, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K202796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2020 |
| Decision Date | September 06, 2021 |
| Days to Decision | 348 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 |