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

    DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500

    K Number: K971753 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    18
    Applicant Total
    4
    Review Days
    46

    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
    DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
    K Number
    K971753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5050
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Denver Biomaterials, Inc.
    Date Received
    May 12, 1997
    Decision Date
    June 27, 1997
    Product Code
    DWM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWM Apparatus, Suction, Patient Care

    Similar 510(k) Clearances

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

    Aspira Pleural Drainage System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Rocket Platinum Cured Cathter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Passio Pump Drainage System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Passio Pump Drainage System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pleurx Pleural Catheter System

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

    Other Clearances by Denver Biomaterials, Inc.

    K Number Device Name
    K973129 DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
    K962814 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    K960456 DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY