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

    ANGIOGRAPHY KIT

    K Number: K821976 · Decision Jul 20, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    92
    Review Days
    14

    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
    ANGIOGRAPHY KIT
    K Number
    K821976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 6, 1982
    Decision Date
    July 20, 1982
    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 Mallinckrodt Critical Care

    K Number Device Name
    K880343 BURNEY GALLBLADDER CATHETER KIT
    K874605 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
    K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
    K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
    K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
    K873461 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
    K873833 THERMOCOUPLE ADAPTER
    K873004 GUIDING CATHETER
    K871204 CUFFED TRACHEAL TUBE (MULTIPLE)
    K862666 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
    Search all 92 clearances from Mallinckrodt Critical Care →