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510(k) Data Aggregation

    K Number
    K103347
    Device Name
    CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, SAS
    Date Cleared
    2011-02-02

    (79 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERVASCULAR, SAS

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

    Woven Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries . Due to the low porosity of Woven vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot fulfill your request with the provided text.

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