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

    RMI SOFCLAMP

    K Number: K920676 · Decision Apr 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    7
    Applicant Total
    35
    Review Days
    61

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    Basic Information

    Device Name
    RMI SOFCLAMP
    K Number
    K920676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Research Medical, Inc.
    Date Received
    February 14, 1992
    Decision Date
    April 15, 1992
    Product Code
    DSS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSS Clip, Vascular

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    Other Clearances by Research Medical, Inc.

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    K961927 RMI HEMOCONCENTRACTOR TUBING SET
    K960098 RMI INTERNAL MAMMARY ARTERY CANNULA
    K951344 RMI HEMOCONCENTRATOR
    K922083 RMI SURGICCAL SITE VISUALIZATION WAND
    K920936 RMI EXTERNAL CORONARY ARTERY OCCLUDER
    K915869 RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
    K910221 RMI VASCULAR TOURNIQUET KIT
    K901231 RMI CARDIOPLEGIA DELIVERY KITS
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