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510(k) Data Aggregation

    K Number
    K981368
    Device Name
    PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1998-05-01

    (16 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K963097
    Why did this record match?
    Reference Devices :

    K963097

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

    Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.

    This product is effective for venous access in adults, children and infants who require intravenous therapy.

    Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).

    Device Description

    PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) notification for a medical device (PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these details based on the given input.

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