LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984294
    Device Name
    MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    1999-02-22

    (83 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

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

    InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

    Device Description

    InterGard Woven Collagen Coated Vascular Prostheses

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "InterGard Woven Collagen Coated Vascular Prostheses." It declares the device substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical validation of the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1