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510(k) Data Aggregation

    K Number
    K190318
    Device Name
    VASOBand Vascular Compression Device
    Date Cleared
    2019-03-14

    (29 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASOInnovations Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VASOBand™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.
    Device Description
    The VASOBand™ Vascular Compression Device is an external compression device used on a human arm and provides a means for a healthcare professional to apply external compression proximal to and/or over a catheterization puncture site for the purpose of assisting post-procedure hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ device is available in two different lengths. The strap measures approximately 26 cm or 29 cm in length and is composed of biocompatible multiple-layer PVC film and PVC tubing, and valves made of biocompatible thermoplastics. Hook and loop material is used to secure the strap in position. Only the biocompatible thermoplastic film comes into contact with broken skin. The user can control the compression applied by the device by introducing or removing air in a bladder of the device.
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