510(k) K253469 · FIE Needle, Fistula
Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSM
| Applicant | Mozarc Medical Us, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Aug 6, 2026 |
| Received | Oct 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253469
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.