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510(k) Data Aggregation

    K Number
    K244047
    Device Name
    Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
    Manufacturer
    Venocare, Inc.
    Date Cleared
    2025-05-23

    (143 days)

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

    Venocare, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
    Device Description
    The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.
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    K Number
    K243105
    Device Name
    Ruby Intravascular Catheter
    Manufacturer
    Venocare, Inc.
    Date Cleared
    2025-05-16

    (228 days)

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

    Venocare, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RUBY Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The RUBY Intravascular Catheter is suitable for use with power injectors. The RUBY Intravascular Catheter is intended to be inserted in the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. The RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10kg) and adults.
    Device Description
    The RUBY™ Intravascular Catheter consists of a radiopaque catheter having a usable length of 1.30 inches in 20-gauge size. The device is a single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor pressure, or administer fluids intravenously. The RUBY™ Intravascular Catheter's hub has a blood control valve mechanism that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter is restricted immediately after needle retraction until a secure luer connection has been made. The RUBY™ Intravascular Catheter is provided with a catheter guiding element with an atraumatic tip design positioned within the formed lumen between the catheter and the needle and connected to a slider used to deploy and retract the catheter guiding element; a flashback chamber to enhance flashback visualization, and a safety container that prevents sharp injuries.
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