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

    POLARCATH PERIPHERAL DILATATION SYSTEM

    K Number: K033622 · Decision Feb 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    POLARCATH PERIPHERAL DILATATION SYSTEM
    K Number
    K033622
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryo Vascular Systems, Inc.
    Date Received
    November 18, 2003
    Decision Date
    February 10, 2004
    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 Cryo Vascular Systems, Inc.

    K Number Device Name
    K051916 POLAR CATH PERIPHERAL DILATATION SYSTEM
    K042230 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
    K042541 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
    K030742 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
    K023463 CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT
    K022061 CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER