LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062594
    Device Name
    MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2006-09-20

    (19 days)

    Product Code
    DQY,LIT
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K083236,K100414
    Predicate For
    K071042
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

    Device Description

    The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

    AI/ML Overview

    This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (PolarCath™ Peripheral Dilatation System) and does not contain information about studies related to AI/algorithm performance, acceptance criteria for such, or details like sample sizes for training/test sets, expert qualifications, or ground truth establishment. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI-powered device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1