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510(k) Data Aggregation

    K Number
    K222679
    Device Name
    Vericor Support Catheter
    Manufacturer
    VascuPatent Medical (Shenzhen) Co. Ltd.
    Date Cleared
    2022-11-07

    (62 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    VascuPatent Medical (Shenzhen) Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vericor Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
    Device Description
    The Vericor Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Vericor Support Catheter will be available in three catheter lengths which are 90 cm, 135 cm and 150 cm. The proposed device is a single-lumen catheter. The hub of the catheter incorporates standard luer adapter to facilitate the attachment of accessories. The outer surface of the distal catheter has a hydrophilic coating. The catheter has three radiopaque markers at the distal end to facilitate fluoroscopic visualization. The device is provided in single use and sterile.
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