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510(k) Data Aggregation

    K Number
    K190351
    Device Name
    Site Seal SV
    Manufacturer
    Ensite Vascular
    Date Cleared
    2019-07-02

    (138 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Site Seal SV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.

    Device Description

    The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Site Seal SV," which is a compression device to assist hemostasis of the radial artery after a transradial procedure.

    This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information. It is purely an FDA clearance letter confirming substantial equivalence to a predicate device and outlining regulatory guidelines.

    Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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