510(k) K132734 ยท FPA Set, Administration, Intravascular
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Oct 8, 2013 |
| Received | Sep 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132734
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2020 | Baxter Healthcare Corporation Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient u Terminated |
FPA | None listed |
| Oct 16, 2015 | Baxter Healthcare Corp ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.