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

    EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

    K Number: K111750 · Decision Jul 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
    K Number
    K111750
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angioslide, Ltd.
    Date Received
    June 22, 2011
    Decision Date
    July 21, 2011
    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 Angioslide, Ltd.

    K Number Device Name
    K172494 PROTEUS PTA Balloon Catheter with Embolic Capture Feature
    K133043 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
    K120164 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
    K120805 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
    K090364 EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE