510(k) K250836 · MPB Catheter, Hemodialysis, Non-Implanted
14F Duo-Flow® Side X Side Double Lumen Catheter
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Aug 12, 2025 |
| Received | Mar 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250836
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.