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

    046 Zenith Flex

    K Number: K190338 · Decision Aug 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    9
    Review Days
    169

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    Basic Information

    Device Name
    046 Zenith Flex
    K Number
    K190338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inneuroco, Inc.
    Date Received
    February 14, 2019
    Decision Date
    August 2, 2019
    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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    Other Clearances by Inneuroco, Inc.

    K Number Device Name
    K232260 Thinline Sheath Introducer
    K220331 091 Balloon Guide Catheter
    K181354 074 Zenith Flex System
    K172167 Zenith Flex System
    K173709 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
    K172468 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
    K171672 065 Zenith, 074 Zenith
    K161262 Super Distal Access (SDA)