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510(k) Data Aggregation

    K Number
    K103367
    Device Name
    SEEKER CROSSING SUPPORT CATHETER
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Date Cleared
    2010-12-08

    (22 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SEEKER CROSSING SUPPORT CATHETER

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

    The Seeker™ Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for the Seeker Crossing Support Catheter, a medical device. It does not contain information about acceptance criteria, device performance, or study details.

    Therefore, I cannot provide the requested information. The document primarily confirms that the FDA has found the device substantially equivalent to pre-existing legally marketed devices.

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