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

Company510(k)sRecalls
Icu Medical, Inc.5106
Baxter Healthcare Corp432
ICU Medical de Mexico, S.A. de C.V.020
B Braun Medical Inc016
Smiths Medical ASD Inc.012
Becton Dickinson & Company011
Elcam Medical Acal80
Merit Medical Systems, Inc.05
Tronomed, Inc.50
American Viggo40
DateFirm and productCodeLinked 510(k)
Dec 2, 2020ICU Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the
Terminated		 FMGK964435
Dec 2, 2020ICU Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non
Terminated		 FMGK964435
Dec 2, 2020ICU Medical, Inc.
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for th
Terminated		 FMGK964435
Jul 1, 2020ICU Medical, Inc.
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravasc
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
Terminated		 FMGK964435
Oct 4, 2019ICU Medical, Inc.
REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
Terminated		 FMGNone listed
Oct 4, 2019ICU Medical, Inc.
REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
Terminated		 FMGK964435
Nov 19, 2018Smiths Medical ASD Inc.
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged
Terminated		 FMGNone listed
Aug 20, 2018ICU Medical, Inc.
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for
Completed		 FMGK964435
May 10, 2018Smiths Medical ASD Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101G
Terminated		 FMGK141254
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, ster
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids f
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
Terminated		 FMGK964435
Mar 1, 2018ICU Medical de Mexico, S.A. de C.V.
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids fro
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemen
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The In
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
7" Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intrav
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
7" Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedica
Terminated		 FMGK964435
Feb 5, 2018ICU Medical, Inc.
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San C
Terminated		 FMGK964435
Nov 17, 2017ICU Medical, Inc.
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer
Terminated		 FMGK964435
Jul 31, 2017ICU Medical, Inc.
120" (305 cm) 10 Drop Primary Set w/2 MicroClave, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, st
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic devi
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, ste
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, ste
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, steril
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, no
Terminated		 FMGK964435
K983559
Jul 31, 2017ICU Medical, Inc.
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a sing
Terminated		 FMGK964435
K983559

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