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510(k) Data Aggregation

    K Number
    K024122
    Device Name
    NAUTICA MICRO CATHETER, MODEL 105-5094-153
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Date Cleared
    2003-03-07

    (81 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K022003,K993672
    Why did this record match?
    Device Name :

    NAUTICA MICRO CATHETER, MODEL 105-5094-153

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

    The MTI Nautica™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.

    Device Description

    The MTI Nautica™ 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

    This document is a 510(k) Pre-market Notification for a medical device called the MTI Nautica™ Micro Catheter, dated December 12, 2002. It outlines the device description, indications for use, and a summary of substantial equivalence to predicate devices. The document also includes the FDA's acceptance letter from March 7, 2003, confirming the substantial equivalence.

    Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are described as follows:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryReported Device Performance
    In-vitro Performance Testing
    Dimensional InspectionPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Tensile Strength TestsPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Burst Pressure TestsPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Flow Rate TestsPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Torque TestsPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Performance under Simulated ConditionsPerformed and results presumably met internal specifications. (Specific values not provided in this summary)
    Biocompatibility
    Compliance with ISO 10993-1Verified in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices).
    Biocompatibility of an external communicating, blood contact, limited exposure (
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