510(k) K061285 ยท FPA Set, Administration, Intravascular
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
| Applicant | Cardinal Health, Alaris Products, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 26, 2006 |
| Received | May 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2021 | CAREFUSION BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E Open, Classified |
FPA | None listed |
| Aug 2, 2021 | CAREFUSION BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.