Search Filters

Search Results

Found 237 results

510(k) Data Aggregation

    K Number
    K243403
    Device 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
    880.5200
    Why 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
    Ask a Question
    K Number
    K251155
    Device 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
    880.5200
    Why 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
    Ask a Question
    K Number
    K243207
    Device Name
    BD Vacutainer® Eclipse™ Blood Collection Needle
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2025-07-03

    (275 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **and Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251654
    Device 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
    880.5200
    Why 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).
    Ask a Question
    K Number
    K250682
    Device 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
    880.5200
    Why 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).
    Ask a Question
    K Number
    K242429
    Device Name
    CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
    Manufacturer
    Becton Dickinson Inc. (BD)
    Date Cleared
    2025-04-09

    (237 days)

    Product Code
    SEF
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    **CentroVena Central Venous Catheter (CVC)** Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. - 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting **CentroVena One Insertion System** The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters. Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. - 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting - 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting
    Device Description
    Vena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories. The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism.
    Ask a Question
    K Number
    K243649
    Device Name
    BD Vacutainer® Multiple Sample Luer Adapter
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2025-03-21

    (115 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **and Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.
    Device Description
    The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood. The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles. Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised. The device consists of the following components: - Non-patient (NP) Cannula - Sleeve - Luer Hub - NP Shield - IV Shield - Epoxy Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.
    Ask a Question
    K Number
    K241586
    Device Name
    PIVO™ Pro Needle-free Blood Collection Device
    Manufacturer
    Becton Dickinson Infusion Therapy Systems, Inc.
    Date Cleared
    2025-02-27

    (269 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **Infusion Therapy Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.
    Device Description
    The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.
    Ask a Question
    K Number
    K242320
    Device Name
    BD Vacutainer® One Use Holder
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2024-11-01

    (88 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **and Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.
    Device Description
    The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.
    Ask a Question
    K Number
    K240455
    Device Name
    BD Vacutainer® Citrate Blood Collection Tubes
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2024-10-31

    (259 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Becton Dickinson **and Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.
    Device Description
    BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.
    Ask a Question

    Page 1 of 24