510(k) K260043 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
| Applicant | Smart Reactors, Galway, IE |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Jan 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260043
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.