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

    Route 92 Medical 070 Access System

    K Number: K203043 · Decision Nov 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    13
    Review Days
    36

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    Basic Information

    Device Name
    Route 92 Medical 070 Access System
    K Number
    K203043
    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
    October 6, 2020
    Decision Date
    November 11, 2020
    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
    K243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
    K240529 8F Modified Sheath System
    K233329 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
    K231583 Route 92 Medical Full Length 054 Access System
    K223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
    K222743 Route 92 Medical Full Length 070 Access System
    K210635 Route 92 Medical Full Length 088 Access System
    K200121 Route 92 Medical 088 Access System, 110 cm
    K191717 Route 92 Medical Sheath System
    K190431 Route 92 Medical Delivery Catheter
    Search all 13 clearances from Route 92 Medical, Inc. →