BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME

    K Number: K001927 · Decision Dec 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    175

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    Basic Information

    Device Name
    VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
    K Number
    K001927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thoratec Laboratories Corp.
    Date Received
    June 26, 2000
    Decision Date
    December 18, 2000
    Product Code
    DSY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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    Other Clearances by Thoratec Laboratories Corp.

    K Number Device Name
    K001926 VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
    K851495 THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY
    K833714 RESPIRATORY ASSESSMENT SYSTEM
    K833265 RESPIRATORY FLOW MODULE
    K831557 INTRAOPERATIVE AUTOTRANSFUSION SYS
    K823449 RESPIRATORY GAS ANALYZER
    K823287 RESPIRATORY CIRCUIT ADAPTOR
    K822769 THORATEC GAS SAMPLING CONNECTOR
    K780247 IMPCO DISPOSABLE AORTIC PUNCH