ClearanceBrief
510(k) K984381 ยท FPA Set, Administration, Intravascular

BURETROL SOLUTION SETS

ApplicantBaxter Healthcare Corp, Round Lake IL, US
DecisionSubstantially Equivalent, Feb 19, 1999
ReceivedDec 8, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K984381

DateFirm and productCodeLinked 510(k)
Oct 9, 2012Baxter 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
FPANone listed
Oct 9, 2012Baxter 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
FPANone listed
Oct 9, 2012Baxter 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
FPANone listed
Oct 9, 2012Baxter 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
FPANone listed
Oct 15, 2010Baxter 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
FPANone listed
Dec 9, 2009Baxter 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
FPANone listed
Mar 24, 2006Baxter 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
FMGNone listed
Mar 24, 2006Baxter 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
FMGNone listed
Mar 24, 2006Baxter 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
FMGNone listed
Nov 26, 2005Baxter 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
FPANone listed
May 17, 2005Baxter 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
FPANone listed
Nov 16, 2004Baxter 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
FPANone listed
Feb 6, 2003Baxter 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
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Vented Buretrol Solution Set, 10 drops/mL; catalog 1C8560; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set, 60 drops/mL; catalog 1C8600; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.