510(k) K962581 ยท FMG Stopcock, I.V. Set
STOPCOCK MANIFOLD GANGS
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Aug 28, 1996 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Sit Terminated |
FMG | None listed |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension Set, 61" (155 cm), Vol. Terminated |
FMG | None listed |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Extension Set, 43" (109 cm), Vol. 6.5 mL, Injection Site, Male Luer Lo Terminated |
FMG | None listed |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lo Terminated |
FMG | None listed |
| Jun 22, 2011 | Baxter Healthcare Corp. Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administra Terminated |
FMG | None listed |
| Dec 9, 2010 | Baxter Healthcare Corp. Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6201.
Intended use Terminated |
FMG | None listed |
| Dec 9, 2010 | Baxter Healthcare Corp. Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6202.
Intended use: For the adminis Terminated |
FMG | None listed |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Interlink System Non-DHEP Extension Set; 8.3" (21.0 cm), Volume 1.4 mL, Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Injection Site, Male Luer Lock Adapter with Retractable Collar; Terminated |
FPA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension s Terminated |
FMG | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway; Terminated |
FMG | 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.