LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060012
    Device Name
    CLIRPATH TURBO PERIPHERAL CATHETERS
    Manufacturer
    SPECTRANETICS CORP.
    Date Cleared
    2006-09-29

    (269 days)

    Product Code
    PDU
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K071227,K140775
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (CLiRpath Turbo Peripheral Catheter). It primarily discusses the substantial equivalence determination and regulatory requirements.

    The document does NOT contain information about acceptance criteria, the specific study conducted, device performance data, sample sizes (training or test), ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

    Therefore, I cannot provide the requested table and detailed information based on the input text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1