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

    EVT ANGIOSCALE ANGIOGRAPHIC CATHETER

    K Number: K970469 · Decision May 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    7
    Review Days
    90

    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
    EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
    K Number
    K970469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guidant Cardiac and Vascular Surgery
    Date Received
    February 7, 1997
    Decision Date
    May 8, 1997
    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 Guidant Cardiac and Vascular Surgery

    K Number Device Name
    K003889 ANCURE SHEATH MODEL # 40315, 40320, 40325
    K001694 GUIDANT RETRIEVER DEVICE
    K003495 ANCURE LLIAC BALLOON CATHETER
    K002676 ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
    K970470 EVT EXPANDABLE SHEATH
    K970608 EVT MARKER BOARD