LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K131869
    Device Name
    PTS-X SIZING BALLOON CATHETER
    Manufacturer
    NUMED, INC.
    Date Cleared
    2013-08-08

    (45 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K160598
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K110903
    Device Name
    PTS-X SIZING BALLOON CATHETER
    Manufacturer
    NUMED, INC.
    Date Cleared
    2011-04-29

    (29 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K041449,K091392,K160598
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the PTS-X Sizing Balloon Catheter. It indicates that the device has been found substantially equivalent to a predicate device.

    The provided text does not contain information regarding acceptance criteria, device performance from a study, sample sizes, expert qualifications, or any details about an AI algorithm. It is a regulatory approval document, not a study report.

    Therefore, I cannot fulfill the request for information about acceptance criteria and a study proving device performance using the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1