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510(k) Data Aggregation

    K Number
    K963335
    Device Name
    HARMAC BALLOON WEDGE PRESSURE CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-16

    (475 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HARMAC BALLOON WEDGE PRESSURE CATHETER

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

    The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.

    Device Description

    Harmac Balloon Wedge Pressure Catheter

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device -- Harmac Balloon Wedge Pressure Catheter. It does not contain sections on acceptance criteria or performance studies. Therefore, I cannot provide the information requested.

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