Panels › General Hospital › Product code FMG · Class 2
Stopcock, I.V. Set
Regulation 880.5440
0510(k)s in 12 months (89 all time)
19recalls in 12 months (207 all time)
204recalls that name a 510(k)
Top companies in FMG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | ICU Medical, Inc. Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage:
The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a pa Terminated |
FMG | K964435 |
| Jun 26, 2017 | ICU Medical, Inc. PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Product Usage:
The device is a single use, sterile, non-pyrogenic device w Terminated |
FMG | K964435 |
| Jun 26, 2017 | ICU Medical, Inc. 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Product Usage:
The device is a single use, sterile, non-pyrogenic device which provides access Terminated |
FMG | K964435 |
| Jun 26, 2017 | ICU Medical, Inc. 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
Product Usage:
The device is a single use, sterile, non-pyrogenic device which provides access Terminated |
FMG | K964435 |
| Jun 26, 2017 | ICU Medical, Inc. 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, Rotating Luer.
Product Usage:
The device is a single use, sterile, non-pyrogenic de Terminated |
FMG | K964435 |
| Jun 26, 2017 | ICU Medical, Inc. 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Product Usage:
The device is a single use, sterile, non-pyrogenic device which provides access Terminated |
FMG | K964435 |
| Feb 2, 2017 | Elcam Medical, Inc. Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls
Product Usage:
indicated for fluid flow directional control and for providing access ports for administratio Terminated |
FMG | K060231 |
| Jan 10, 2017 | ICU Medical, Inc. 133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006
Product Usage:
The intravascular administration set is a single use, sterile, non-pyrogenic de Terminated |
FMG | K964435 |
| Dec 18, 2015 | Value Plastics, Inc. Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags con Terminated |
FMG | K792125 |
| May 7, 2015 | ICU Medical, Inc. 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372
Product Usage:
IV Administration sets are intended for the infusion and withdrawal of fl Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338
Product Usage:
IV Administration sets Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351
Product Usage:
IV Administration sets are intended for the infus Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326 Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33 Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065
Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041
Product Usage:
IV Administration sets are intended for the infusion and withdraw Terminated |
FMG | K964435 |
| May 7, 2015 | ICU Medical, Inc. 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037
Pr Terminated |
FMG | K964435 |
| Sep 19, 2014 | ICU Medical, Inc. 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648.
Product Usage:
IV Administration sets are intended for the infusion and withdraw Terminated |
FMG | K964435 |
| Sep 19, 2014 | ICU Medical, Inc. 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897.
Product Usage:
IV Administration sets are intended for the infusion and withd Terminated |
FMG | K964435 |
| Sep 19, 2014 | ICU Medical, Inc. STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set
w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802.
Product Usage:
IV Administration sets are intended for the Terminated |
FMG | K964435 |
| Sep 19, 2014 | ICU Medical, Inc. STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set
w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801.
Product Usage:
IV Administration sets are intended for the Terminated |
FMG | K964435 |
| Aug 2, 2012 | ICU Medical, Inc. 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi)
Stopcock, Rotating Luer, Non-DEHP Tubing Terminated |
FMG | K964435 |
| 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 | K962581 |
| 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 | K962581 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" Terminated |
FMG | K932512 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set Terminated |
FMG | K932512 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, no Terminated |
FMG | K932512 |
| 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 | K962581 |
| 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 | K962581 |
| 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 | K962581 |
| 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 | K962581 |
| 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 | K962581 |
| Sep 16, 2008 | ICU Medical, Inc. ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843
Indicated for fluid flow directional control and for providing access port(s) for administration of Terminated |
FMG | K060231 |
| Sep 16, 2008 | ICU Medical, Inc. Hospira Left Heart Kit for Southwestern M.C. , Item Number: 46084053
Indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Terminated |
FMG | K060231 |
| Sep 16, 2008 | ICU Medical, Inc. Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item Number: 460760451
Indicated for fluid flow directional control and for providing access port(s) for administra Terminated |
FMG | K060231 |
| Sep 16, 2008 | ICU Medical, Inc. Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401
Indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Terminated |
FMG | K060231 |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah. Terminated |
FMG | K915678 |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, South Jordan, Utah. Terminated |
FMG | K915678 |
| May 31, 2007 | Merit Medical Systems, Inc. Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMG | K915678 |
| May 31, 2007 | Merit Medical Systems, Inc. Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. Terminated |
FMG | K915678 |
| May 31, 2007 | Merit Medical Systems, Inc. Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMG | K915678 |
| 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 | K022895 K921899 +2 |
| 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 | K022895 K962581 +1 |
| 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 | K022895 K921899 +2 |
| 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 | K022895 K921899 +2 |
| 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 | K022895 K811078 +3 |
| Jun 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Terminated |
FMG | K022895 |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex High Pressure 4 - Way Stopcock
Catalog Number: T8202 Terminated |
FMG | K851986 |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex High Pressure 1 - Way Stopcock
Catalog Number: T8200 Terminated |
FMG | K851986 |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex ULTRA-FLO 4 Way Stopcock
Catalog Number: T1210 Terminated |
FMG | K851986 |
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