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510(k) Data Aggregation

    K Number
    K253205

    Validate with FDA (Live)

    Device Name
    OptiMap Catheter - 50mm (OPTI-CATH2-50)
    Manufacturer
    Cortex, Inc.
    Date Cleared
    2026-03-13

    (168 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K223666
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OptiMap™ Catheter is indicated for use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e. linear mapping catheters). The OptiMap™ Catheter may also be used for delivery of externally generated pacing stimuli.

    Device Description

    The OptiMap™ Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. It may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system.

    The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into a minimum 8.5 F sheath. The OptiMap Catheter is available in one model number representing its basket size.

    • OPTI-CATH2-50 is the 50 mm basket size
    AI/ML Overview

    N/A

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