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

    Route 92 Medical Full Length 088 Access System

    K Number: K210635 · Decision Jul 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    13
    Review Days
    146

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    Basic Information

    Device Name
    Route 92 Medical Full Length 088 Access System
    K Number
    K210635
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Route 92 Medical, Inc.
    Date Received
    March 3, 2021
    Decision Date
    July 27, 2021
    Product Code
    QJP
    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
    QJP Catheter, Percutaneous, Neurovasculature

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    Other Clearances by Route 92 Medical, Inc.

    K Number Device Name
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    K231583 Route 92 Medical Full Length 054 Access System
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    K222743 Route 92 Medical Full Length 070 Access System
    K203043 Route 92 Medical 070 Access System
    K200121 Route 92 Medical 088 Access System, 110 cm
    K191717 Route 92 Medical Sheath System
    K190431 Route 92 Medical Delivery Catheter
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