510(k) K123874 ยท FPA Set, Administration, Intravascular
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Jan 10, 2013 |
| Received | Dec 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites
Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic Terminated |
FPA | None listed |
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***BURETROL Solution Set***105" (2.7 m)
150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyr Terminated |
FPA | None listed |
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***Non-DEHP***BURETROL Solution Set
105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve
3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.