ClearanceBrief
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)
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Top companies in FMG

DateFirm and productCodeLinked 510(k)
Jun 26, 2017ICU 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
FMGK964435
Jun 26, 2017ICU 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
FMGK964435
Jun 26, 2017ICU 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
FMGK964435
Jun 26, 2017ICU 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
FMGK964435
Jun 26, 2017ICU 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
FMGK964435
Jun 26, 2017ICU 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
FMGK964435
Feb 2, 2017Elcam 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
FMGK060231
Jan 10, 2017ICU 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
FMGK964435
Dec 18, 2015Value 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
FMGK792125
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
May 7, 2015ICU 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
FMGK964435
Sep 19, 2014ICU 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
FMGK964435
Sep 19, 2014ICU 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
FMGK964435
Sep 19, 2014ICU 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
FMGK964435
Sep 19, 2014ICU 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
FMGK964435
Aug 2, 2012ICU Medical, Inc.
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Terminated
FMGK964435
Jan 11, 2012Baxter 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
FMGK962581
Jan 11, 2012Baxter 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
FMGK962581
Jan 11, 2012Baxter 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
FMGK932512
Jan 11, 2012Baxter 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
FMGK932512
Jan 11, 2012Baxter 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
FMGK932512
Jan 11, 2012Baxter 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
FMGK962581
Jan 11, 2012Baxter 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
FMGK962581
Jun 22, 2011Baxter 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
FMGK962581
Dec 9, 2010Baxter 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
FMGK962581
Dec 9, 2010Baxter 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
FMGK962581
Sep 16, 2008ICU 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
FMGK060231
Sep 16, 2008ICU 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
FMGK060231
Sep 16, 2008ICU 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
FMGK060231
Sep 16, 2008ICU 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
FMGK060231
May 31, 2007Merit Medical Systems, Inc.
Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.
Terminated
FMGK915678
May 31, 2007Merit Medical Systems, Inc.
Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, South Jordan, Utah.
Terminated
FMGK915678
May 31, 2007Merit 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
FMGK915678
May 31, 2007Merit Medical Systems, Inc.
Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000.
Terminated
FMGK915678
May 31, 2007Merit Medical Systems, Inc.
Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Terminated
FMGK915678
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
FMGK022895
K921899 +2
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
FMGK022895
K962581 +1
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
FMGK022895
K921899 +2
Mar 24, 2006Baxter 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
FMGK022895
K921899 +2
Mar 24, 2006Baxter 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
FMGK022895
K811078 +3
Jun 30, 2005Baxter 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
FMGK022895
Nov 24, 2004Smiths Medical ASD, Inc.
Portex High Pressure 4 - Way Stopcock Catalog Number: T8202
Terminated
FMGK851986
Nov 24, 2004Smiths Medical ASD, Inc.
Portex High Pressure 1 - Way Stopcock Catalog Number: T8200
Terminated
FMGK851986
Nov 24, 2004Smiths Medical ASD, Inc.
Portex ULTRA-FLO 4 Way Stopcock Catalog Number: T1210
Terminated
FMGK851986

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