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

    DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

    K Number: K950440 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    16
    Review Days
    231

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
    K Number
    K950440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J-Lloyd Medical, Inc.
    Date Received
    January 27, 1995
    Decision Date
    September 15, 1995
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.

    Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arterial Pressure Monitoring Set/Tray

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DualView Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    pNOVUS 21 Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Impress Angiographic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by J-Lloyd Medical, Inc.

    K Number Device Name
    K973639 ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
    K971504 HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
    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)
    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. →