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

    CHASE CARDIOVASCULAR PATCH KIT

    K Number: K020132 · Decision Feb 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    27
    Review Days
    42

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    Basic Information

    Device Name
    CHASE CARDIOVASCULAR PATCH KIT
    K Number
    K020132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chase Medical, Inc.
    Date Received
    January 15, 2002
    Decision Date
    February 26, 2002
    Product Code
    DXZ
    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
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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    Other Clearances by Chase Medical, Inc.

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    K020233 CHASE CARDIOVASCULAR PATCH KIT
    K012248 CHASE CARDIOVASCULAR PATCH
    K003467 CHASE CARDIOVASCULAR PATCH
    K001662 CHASE CARDIOVASCULAR PATCH
    K972993 CHASE FEMORAL ACCESS CANNULATION SET
    K974568 CHASE ANASTOMOSIS VISUALIZATION DEVICE
    K971013 CHASE TEMPERATURE PROBE
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