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

    TRANSLUCENT POLY. CATH. CONNECTOR AND

    K Number: K830237 · Decision Feb 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    21
    Review Days
    24

    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
    TRANSLUCENT POLY. CATH. CONNECTOR AND
    K Number
    K830237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vertex Medical Corp.
    Date Received
    January 25, 1983
    Decision Date
    February 18, 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 Vertex Medical Corp.

    K Number Device Name
    K833742 ESCHMANN DILATION CATHETER
    K834476 NEPHROSTOMY/BILIARY DRAINAGE BAG
    K832380 PROTECTIVE SLEEVE
    K831666 SIALOGRAPHY NEEDLE
    K830576 LYMPHANGIOGRAPHY SET
    K830420 POLYETHYLENE MONITORING CONNECTORS
    K823192 TUOHY-BORST ADAPTER W/SIDE ARM
    K823253 VERTEX MONITORING CATHETER
    K823256 ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
    K823254 REUSABLE METAL STOPCOCK
    Search all 21 clearances from Vertex Medical Corp. →