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

    HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

    K Number: K971504 · Decision Apr 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    16
    Review Days
    360

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    Basic Information

    Device Name
    HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
    K Number
    K971504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J-Lloyd Medical, Inc.
    Date Received
    April 25, 1997
    Decision Date
    April 20, 1998
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by J-Lloyd Medical, Inc.

    K Number Device Name
    K973639 ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
    K974335 EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
    K974336 CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
    K963248 FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
    K950440 DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
    K940547 FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
    K935405 ARTERIAL EMBOLECTOMY
    K935403 WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
    K935404 FLOW DIRECTED THERMODILUTION BALLOON CATHETER
    K935402 ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
    Search all 16 clearances from J-Lloyd Medical, Inc. →