LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150201
    Device Name
    Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
    Manufacturer
    SPECTRANETICS, INC.
    Date Cleared
    2015-02-27

    (29 days)

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

    Quick-Cross® Extreme and Select Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

    Device Description

    Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Quick-Cross Extreme and Select Support Catheters. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and contact information but does not include clinical study data or performance metrics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1