ClearanceBrief
Panels › General Hospital › Product code FPA · Class 2

Set, Administration, Intravascular

Regulation 880.5440

6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set, REF: ME1069
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Open, Classified
FPAK051499
Aug 1, 2022ICU Medical, Inc.
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Open, Classified
FPANone listed
Aug 1, 2022ICU Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Open, Classified
FPAK082806
Aug 1, 2022ICU Medical, Inc.
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Open, Classified
FPAK100576
Aug 1, 2022ICU Medical, Inc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
Open, Classified
FPAK100434
Oct 28, 2021Stradis Medical, LLC dba Stradis Healthcare
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Terminated
FPAK993463
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
Terminated
FPAK922637
K931377
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid
Terminated
FPAK922637
K931377
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Terminated
FPAK913661
Aug 10, 2021B. Braun Medical, Inc.
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
Terminated
FPAK140311
K913661
Aug 10, 2021B. Braun Medical, Inc.
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Terminated
FPAK083723
K913661
Aug 10, 2021B. Braun Medical, Inc.
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
Terminated
FPAK140311
K913661 +1
Aug 10, 2021B. Braun Medical, Inc.
OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
Terminated
FPAK140311
K913661
Aug 10, 2021B. Braun Medical, Inc.
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Terminated
FPAK140311
K922637
Aug 10, 2021B. Braun Medical, Inc.
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Terminated
FPAK083723
K904518 +1
Aug 10, 2021B. Braun Medical, Inc.
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Terminated
FPAK913661
Aug 10, 2021B. Braun Medical, Inc.
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Terminated
FPAK913661
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Terminated
FPAK781744
K913661
Aug 10, 2021B. Braun Medical, Inc.
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Terminated
FPAK083723
K922637
Aug 10, 2021B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Terminated
FPAK083723
K781744 +1
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 35421
Terminated
FPAK083723
K913661 +1
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Terminated
FPAK083723
K913661
Aug 10, 2021B. Braun Medical, Inc.
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Terminated
FPAK083723
K913661
Aug 2, 2021CAREFUSION
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
Open, Classified
FPAK970485
Aug 2, 2021CAREFUSION
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Lue
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Open, Classified
FPAK931550
Aug 2, 2021CAREFUSION
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Open, Classified
FPAK780130
Aug 2, 2021CAREFUSION
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522
Open, Classified
FPAK931173
Aug 2, 2021CAREFUSION
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Open, Classified
FPAK951922
Aug 2, 2021CAREFUSION
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Open, Classified
FPAK970485
Aug 2, 2021CAREFUSION
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smart
Open, Classified
FPAK944320
Aug 2, 2021CAREFUSION
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Open, Classified
FPAK820278
Aug 2, 2021CAREFUSION
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
Open, Classified
FPAK811885
Aug 2, 2021CAREFUSION
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV ,
Open, Classified
FPAK780130
Aug 2, 2021CAREFUSION
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Open, Classified
FPAK061285
Aug 2, 2021CAREFUSION
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Open, Classified
FPAK061285
Jun 25, 2021B. Braun Medical, Inc.
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Terminated
FPAK142036
Jun 9, 2021CAREFUSION
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiratio
Terminated
FPANone listed
Mar 16, 2021ICU Medical, Inc.
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathete
Open, Classified
FPAK082806
Mar 16, 2021ICU Medical, Inc.
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets
Open, Classified
FPAK082806
Mar 16, 2021ICU Medical, Inc.
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a conta
Open, Classified
FPAK082806
Mar 16, 2021ICU Medical, Inc.
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Open, Classified
FPAK081361
Mar 16, 2021ICU Medical, Inc.
REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Open, Classified
FPAK081361

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