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

    HALO360' COAGULATION CATHETER

    K Number: K071543 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    13
    Review Days
    24

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    Basic Information

    Device Name
    HALO360' COAGULATION CATHETER
    K Number
    K071543
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barrx Medical, Incorporated
    Date Received
    June 5, 2007
    Decision Date
    June 29, 2007
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Barrx Medical, Incorporated

    K Number Device Name
    K093855 HALO 360 & SIZING BALLOON, MODEL 3441C
    K093008 HALO ABLATION CATHETER, MODEL 90-9100
    K092487 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
    K083737 HALO ABLATION CATHETER
    K083711 MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
    K082202 HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
    K080557 BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
    K062441 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020
    K062723 HALO90 COAGULATION CATHETER
    K062225 HALO COAGULATION CATHETER
    Search all 13 clearances from Barrx Medical, Incorporated →