LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030688
    Device Name
    ECHELON MICRO CATHETER, MODEL 105-5092-150
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Date Cleared
    2003-03-28

    (23 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K993672
    Why did this record match?
    Device Name :

    ECHELON MICRO CATHETER, MODEL 105-5092-150

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MTI Echelon™ Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

    Device Description

    The MTI Echelon™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.

    AI/ML Overview

    The provided text describes a Special 510(k) submission for the Echelon™ Micro Catheter, which is a modification to the previously cleared Rebar® Micro Catheter (K993672). As such, the submission focuses on demonstrating substantial equivalence to the predicate device through performance testing rather than establishing de novo clinical efficacy for a novel device. Therefore, many of the requested categories related to clinical studies, AI performance, and expert ground truth are not applicable to this type of submission.

    Here's a summary of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission describes in-vitro performance testing and biocompatibility testing. The "acceptance criteria" themselves are not explicitly detailed as quantitative thresholds in the provided text, but rather implied by successful completion of these tests to demonstrate substantial equivalence to the predicate device.

    Acceptance Criteria (Implied)Reported Device Performance
    Dimensional specifications metDimensional inspection performed (results not detailed, but implied met for clearance)
    Tensile strength within acceptable limitsTensile strength tests performed (results not detailed, but implied met for clearance)
    Burst pressure within acceptable limitsBurst pressure tests performed (results not detailed, but implied met for clearance)
    Flow rate within acceptable limitsFlow rate tests performed (results not detailed, but implied met for clearance)
    Torque characteristics within acceptable limitsTorque tests performed (results not detailed, but implied met for clearance)
    Performance under simulated conditions equivalent to predicatePerformance under simulated conditions tested (results not detailed, but implied met for clearance)
    Biocompatibility in accordance with ISO 10993-1Biocompatibility verified as an external communicating, blood contact, limited exposure (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1