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510(k) Data Aggregation

    K Number
    K250292
    Device Name
    OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
    Manufacturer
    SkyDance Vascular, Inc.
    Date Cleared
    2025-05-02

    (91 days)

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

    SkyDance Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSPREY Midline Closed IV Catheter System (OspreyEDC) is an intravascular catheter intended to be inserted into the patient’s vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Midline Closed IV Catheter System (OspreyEDC) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.
    Device Description
    The OSPREY Midline Closed IV Catheter System (OspreyEDC) has a usable (deployed) catheter length of 3.25 inches. The device is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (<30 days) use. The device is constructed with a clear housing having integrated wings and ribs to assist with its handling, a beveled needle that allows the catheter to be deployed through it and the needle fully and permanently passively retracts into the housing when the catheter hub with its integrated extension tube, including an incorporated pinch clamp, female luer with porous (vent) plug is fully advanced via the wire slider with integrated stainless steel guidewire. The device is placed in a thermal formed tray that goes into a Tyvek pouch providing the sterile barrier.
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    K Number
    K231626
    Device Name
    OSPREY Closed IV Catheter System (OspreyV2)
    Manufacturer
    SkyDance Vascular, Inc.
    Date Cleared
    2023-08-31

    (90 days)

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

    SkyDance Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSPREY Closed IV Catheter System (OspreyV2) is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.
    Device Description
    The OPREY Closed IV Catheter System (OspreyV2) is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (<30 days) use. The device is constructed with a clear housing having integrated wings and ribs to assist with its handling, a beveled needle that allows the catheter to be deployed through it and the needle fully and permanently passively retracts into the housing when the catheter hub with its integrated extension tube, including an incorporated pinch clamp, female luer with porous (vent) plug is fully advanced. The device is placed in a thermal formed tray that goes into a Tyvek pouch providing the sterile barrier.
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    K Number
    K223018
    Device Name
    OSPREY PERIPHERAL IV Catheter System
    Manufacturer
    SkyDance Vascular, Inc.
    Date Cleared
    2023-04-14

    (197 days)

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

    SkyDance Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    The OPREY IV Catheter System is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood pressure, or administer fluids intravenously. The device has a usable length catheter of 1.67 inches in a 20 Gauge size for short-term (<30 days) use.
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