K171952 is an FDA 510(k) clearance for the Dimesol Tubing Sets for Hemodialysis, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Dimesol, Inc. (Lewisberry, US). The FDA issued a Cleared decision on March 30, 2018, 274 days after receiving the submission on June 29, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K171952 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 29, 2017 |
| Decision Date | March 30, 2018 |
| Days to Decision | 274 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 |