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

    CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

    K Number: K193380 · Decision Jul 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    152
    Review Days
    228

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    Basic Information

    Device Name
    CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
    K Number
    K193380
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    December 5, 2019
    Decision Date
    July 20, 2020
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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