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510(k) Data Aggregation

    K Number
    K011937
    Date Cleared
    2001-08-28

    (68 days)

    Product Code
    Regulation Number
    880.5200
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.

    Device Description

    The MTI Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area of the Reinforced Infusion Catheter is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The Reinforced Infusion Catheters are available in a variety of infusion lengths.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Micro Therapeutics, Inc. Reinforced Infusion Catheter, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CriteriaDevice Performance
    Biocompatibility (in accordance with ISO 10993-1 for external communicating, blood contact, limited exposure (
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