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510(k) Data Aggregation
K Number
K243403Device Name
BD Nexiva Closed IV Catheter System
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-07-25
(267 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K251155Device Name
BD Cathena Safety IV Catheter
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-07-11
(88 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K251654Device Name
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-06-27
(28 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
**BD Insyte™ Autoguard™ Shielded IV Catheter** is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may also be used to facilitate the placement of guidewires and other vascular access devices such as catheters without pre-attached hubs. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
**BD Insyte™ Autoguard™ BC Shielded IV Catheter** is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
**BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter** is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
Device Description
BD Insyte™ Autoguard™ Shielded IV Catheter is an over-the-needle, intravascular (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.
The 24-20 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.
BD Insyte™ Autoguard™ Shielded IV Catheter incorporates BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.
BD Insyte™ Autoguard™ Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey, 14 GA (2.1 mm) = Orange).
BD Insyte™ Autoguard™ Shielded IV Catheter facilitates the introduction of guidewires and other vascular access devices. The following labeled gauge sizes correspond to the following inside diameter (ID): 24 GA (0.40 mm ID), 22 GA (0.55 mm ID), 20 GA (0.7 mm ID), 18 GA (0.8 mm ID), 16 GA (1.2 mm ID), and 14 GA (1.6 mm ID).
The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
**BD Insyte™ Autoguard™ BC Shielded IV Catheter** is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.
The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.
The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.
BD Insyte™ Autoguard™ BC Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.
BD Insyte™ Autoguard™ BC Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).
The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
**BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter** is an over-the-needle, intravascular (IV) catheter with blood control technology. This device includes a radiopaque BD Vialon™ Catheter Material, a needle, a grip with button, a flash chamber with vent plug, and a barrel. The needle and catheter are protected by a needle cover.
The blood control technology is designed to stop the flow of blood from the catheter hub until the initial Luer connection is made. Once the connection is made, fluids or blood can flow through the catheter hub in either direction.
The 24-18 GA (0.7-1.1 mm) devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel.
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter incorporate BD Autoguard™ Push-button Shielding Technology which is activated when the button is depressed. A spring mechanism retracts the needle and flash chamber into the barrel, fully encasing the needle and reducing the risk of accidental needlestick injury.
BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey).
The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa).
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K Number
K250682Device Name
BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-06-03
(89 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Device Description
BD Nexiva™ Diffusics™ Closed IV Catheter Systems (Nexiva Diffusics) and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Nexiva Diffusics with Max Zero) are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ Catheter Material with three side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package.
A BD MaxZero™ device with protective cover is provided in the unit package for BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector kit. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needle stick injury.
These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
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K Number
K233529Device Name
BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2023-12-01
(29 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Device Description
BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with three side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. A BD MaxZero™ device with protective cover is provided in the unit package.
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K Number
K231239Device Name
Nexiva Closed IV Catheter System with NearPort IV Access
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2023-09-22
(147 days)
Product Code
FOZ, FPA
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is intended to be inserted into a patient's peripheral venous system for short term use to administer fluids and/or medications and to sample blood. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 24-18 GA (0.7-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when connected to the NearPort™ IV Access.
Device Description
The Nexiva™ Closed IV Catheter System with NearPort™ IV Access is an over-the-needle, intravenous (IV) catheter. These devices have a radiopaque Vialon™ catheter tubing, needle, needle shield, septum, stabilization platform, long extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter tubing are protected by a needle cover. A MaxZero™ needle-free connector with protective cover is provided in the package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have Instaflash™ Needle Technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the long extension tubing. The vent plug and the NearPort™ IV Access prevent blood leakage from the long extension tubing during insertion. Both the long extension tubing and NearPort™ IV Access are suitable to administer fluids and/or medications and to sample blood. In addition, the NearPort™ IV Access is compatible with the PIVO™ Pro Needle-free Blood Collection Device for needle-free blood draws and is suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa). These devices are available with wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
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K Number
K220584Device Name
BD Cathena Safety IV Catheter
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2022-03-31
(30 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
Device Description
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the cather direction.
These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
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K Number
K201717Device Name
BD Cathena Safety IV Catheter
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2020-09-22
(91 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
Device Description
BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.
These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
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K Number
K183399Device Name
BD Nexiva Closed IV Catheter System
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2019-03-20
(103 days)
Product Code
FOZ, FPA
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Nexiva closed IV catheter systems are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Device Description
BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needleless connector (BD Q-Syte or MaxZero) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte, MaxZero, or end cap with protective cover is provided in the unit package (not available with all configurations).
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
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K Number
K143610Device Name
BD INTIMA II CLOSED IV CATHETER
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2015-04-09
(111 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Infusion Therapy Systems Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy.
Device Description
The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter. The closed system is designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque VialonTM material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp), extension tubing and Luer connector. It incorporates an integrated extension set which is available in two configurations: Y Connection (dual port) and Straight Connection (single port). The Luer connector is color-coded to indicate catheter gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain the sterility during its specified shelf life of 3 years.
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