Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252405

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (118 days)

    Product Code
    Regulation Number
    870.1220
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

    Device Description

    The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic Tip Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1