LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982888
    Device Name
    VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1998-10-20

    (64 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

    Device Description

    The port kit provides an implantable port and polyurethane catheter, an introducer sheath/dilator, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" guidewire.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary and an FDA letter, which primarily discusses the substantial equivalence of the Vaxcel Implantable Vascular Access System to predicate devices and regulatory compliance.

    Therefore, I cannot populate the table or answer the specific questions about studies and data.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1