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

    Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

    K Number: K223530 · Decision Apr 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    13
    Review Days
    139

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    Basic Information

    Device Name
    Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
    K Number
    K223530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Route 92 Medical, Inc.
    Date Received
    November 23, 2022
    Decision Date
    April 11, 2023
    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 Route 92 Medical, Inc.

    K Number Device Name
    K243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
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    K233329 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
    K231583 Route 92 Medical Full Length 054 Access System
    K222743 Route 92 Medical Full Length 070 Access System
    K210635 Route 92 Medical Full Length 088 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
    Search all 13 clearances from Route 92 Medical, Inc. →