BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PROTEUS PTA Balloon Catheter with Embolic Capture Feature

    K Number: K172494 · Decision Dec 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    6
    Review Days
    119

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    Basic Information

    Device Name
    PROTEUS PTA Balloon Catheter with Embolic Capture Feature
    K Number
    K172494
    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
    August 18, 2017
    Decision Date
    December 15, 2017
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Angioslide, Ltd.

    K Number Device Name
    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
    K111750 EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
    K090364 EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE