510(k) K984381 ยท FPA Set, Administration, Intravascular
BURETROL SOLUTION SETS
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Feb 19, 1999 |
| Received | Dec 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the administration of fluids Terminated |
FPA | None listed |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device;
Product Usage: The device is used for t Terminated |
FPA | None listed |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the a Terminated |
FPA | None listed |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device
Product Usage: The device is used Terminated |
FPA | None listed |
| Oct 15, 2010 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Loc Terminated |
FPA | None listed |
| Dec 9, 2009 | Baxter Healthcare Corp. Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic f Terminated |
FMG | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set and Minivolume Extension Set, product code 3C0128; An Rx sterile, nonpyrogenic fluid pathway; solution set: 1 Terminated |
FMG | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathw Terminated |
FMG | None listed |
| Nov 26, 2005 | Baxter Healthcare Corp. Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | None listed |
| May 17, 2005 | Baxter Healthcare Corp. Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless Terminated |
FPA | None listed |
| Nov 16, 2004 | Baxter Healthcare Corp. Baxter Clearlink Intravenous (IV) Delivery System; the system consists of solution sets, extension sets and blood sets that have a luer activated valve for IV access, which allows the administration Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Vented Buretrol Volumetric Pump Solution Set, 10 drops/mL; catalog 1C8384; 10 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Vented Buretrol Solution Set, 10 drops/mL; catalog 1C8560; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 60 drops/mL; catalog 1C8600; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
| Feb 6, 2003 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.