510(k) K151079 ยท FPA Set, Administration, Intravascular
Q2 Intravenous Adminstration Sets and Extension Sets
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Sep 30, 2015 |
| Received | Apr 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2023 | Quest Medical, Inc. Q2 Multiport Extension set, REF: 9520, Rx Only
Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needl Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.