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

    RADIUS SNARE

    K Number: K070502 · Decision Oct 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    9
    Review Days
    225

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    Basic Information

    Device Name
    RADIUS SNARE
    K Number
    K070502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radius Medical Technologies, Inc.
    Date Received
    February 21, 2007
    Decision Date
    October 4, 2007
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Radius Medical Technologies, Inc.

    K Number Device Name
    K071457 MODIFICATION TO RADIUS SNARE
    K032899 RADIUS COUGAR WIRE
    K032129 RADIUS 018 COUGAR WIRE
    K022201 RADIUS MICRO SNARE
    K021441 RADIUS SNARE
    K011759 RADIUS NEXT GENERATION GUIDEWIRE
    K011287 RADIUS COUGAR WIRE
    K970466 RADIUS PTCA GUIDEWIRE