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

    CATHETER CONNECTION W/INTEGRAL INJECTATE

    K Number: K830523 · Decision Mar 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    31
    Review Days
    27

    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
    CATHETER CONNECTION W/INTEGRAL INJECTATE
    K Number
    K830523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gould, Inc.
    Date Received
    February 17, 1983
    Decision Date
    March 16, 1983
    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 Gould, Inc.

    K Number Device Name
    K911935 CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
    K861092 MODEL SP1465 CARDIAC OUTPUT COMPUTER
    K860805 PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
    K855145 MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
    K854403 MODEL 2120 SPIROSCREEN
    K851486 GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
    K850114 C/PES 9201, ECG STRESS TESTING SYS
    K850113 C/PES 9103, ECG STRESS TESTING SYSTEM
    K843555 CARDIAC COMPUTER SP1445
    K843969 MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
    Search all 31 clearances from Gould, Inc. →