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

    TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV

    K Number: K002816 · Decision Nov 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    16
    Review Days
    72

    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
    TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
    K Number
    K002816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Transonic Systems, Inc.
    Date Received
    September 11, 2000
    Decision Date
    November 22, 2000
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

    Similar 510(k) Clearances

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

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Blood Tubing Lines for Hemodialysis AV06C-E

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAREline Airless Hemodialysis Blood Tubing Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Transonic Systems, Inc.

    K Number Device Name
    K140740 TRANSONIC TISSUE PERFUSION MONITOR
    K134051 TRANSONIC ELSA SYSTEM
    K134035 TRANSONIC HCM 103 SYSTEM
    K140017 TRANSONIC HCM 102 SYSTEM
    K113821 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
    K112657 AUREFLO MONITORING SYSTEM
    K080116 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
    K033424 ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
    K022963 TRANSONIC SYRINGE WARMER, MODEL SYR-1000
    K021571 TRANSONIC FLOW-QC SET MODEL ADT1010
    Search all 16 clearances from Transonic Systems, Inc. →