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)
Jul 24, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
Terminated
FPAK013871
Jul 24, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
Terminated
FPAK060944
Jun 30, 2017CareFusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or
Terminated
FPAK945070
Jun 19, 2017ConMed Corporation
STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2)
Terminated
FPAK964844
May 15, 2017Smiths Medical ASD Inc.
CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV b
Terminated
FPAK031361
Apr 10, 2017B Braun Medical Inc
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Terminated
FPAK112636
Mar 30, 2017Smiths Medical ASD Inc.
CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
Terminated
FPAK040636
Mar 29, 2017Angiodynamics Inc. (Navilyst Medical Inc.)
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Terminated
FPAK852140
Feb 28, 2017CareFusion 303, Inc.
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or cathete
Terminated
FPAK051499
Feb 28, 2017CareFusion 303, Inc.
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Terminated
FPAK051499
Feb 20, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Terminated
FPAK021395
Jan 10, 2017Bard Access Systems
SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton. Product Usage: Inten
Terminated
FPAK040527
Jan 10, 2017Bard Access Systems
MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton. Product U
Terminated
FPAK050600
Jan 10, 2017ICU Medical, Inc.
Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intr
Terminated
FPAK053106
Dec 23, 2016Becton Dickinson & Company
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickins
Terminated
FPAK160651
Dec 9, 2016Smiths Medical ASD Inc.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Terminated
FPAK933390
Nov 21, 2016Merit Medical Systems, Inc.
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Terminated
FPAK915678
Nov 18, 2016Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Terminated
FPAK021395
Nov 17, 2016CareFusion 303, Inc.
SmartSite Add-On Bag Access Device, Model No. 10013365
Terminated
FPAK970485
Sep 27, 2016Zyno Medical LLC
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to adminis
Terminated
FPAK132841
Sep 27, 2016Zyno Medical LLC
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Med
Terminated
FPAK132841
Sep 27, 2016Zyno Medical LLC
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to admini
Terminated
FPAK132841
Sep 27, 2016Zyno Medical LLC
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Med
Terminated
FPAK132841
Jun 14, 2016WalkMed Infusion, LLC
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or cat
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a containe
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle o
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter in
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter insert
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inse
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle o
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted in
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter
Terminated
FPAK073444
Jun 14, 2016WalkMed Infusion, LLC
Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into
Terminated
FPAK073444
Apr 22, 2016Smiths Medical ASD, Inc.
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-733
Terminated
FPAK040636
Feb 23, 2016Centurion Medical Products Corporation
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus Needless IV Connectors are used for single patient use in IV and blood admin
Terminated
FPANone listed
Feb 15, 2016CareFusion 303, Inc.
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Terminated
FPAK944320
Feb 3, 2016Global Healthcare Inc
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Terminated
FPAK083687
Jan 21, 2016Rymed Technologies, LLC
InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need
Terminated
FPAK093489
Jan 21, 2016Rymed Technologies, LLC
InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for n
Terminated
FPAK991653
Dec 17, 2015CareFusion 303, Inc.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Terminated
FPAK944320
Nov 30, 2015Baxter Healthcare Corp.
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patient
Terminated
FPAK860272
Nov 30, 2015Baxter Healthcare Corp.
Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
Terminated
FPAK860272
Nov 5, 2015CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Terminated
FPAK960280
Oct 16, 2015Baxter Healthcare Corp
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Terminated
FPAK132734
Jun 19, 2015Unomedical As
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Terminated
FPAK120395

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