510(k) K130725 ยท FOS Catheter, Umbilical Artery
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
| Applicant | Covidien Lp, Formerly Registered AS Kendall, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 17, 2013 |
| Received | Mar 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130725
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen Open, Classified |
FOS | None listed |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen Open, Classified |
FOS | None listed |
| May 29, 2025 | Cardinal Health 200, LLC Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen Open, Classified |
FOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.