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

    ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT

    K Number: K080400 · Decision May 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    87
    Review Days
    90

    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
    ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
    K Number
    K080400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AngioDynamics, Inc.
    Date Received
    February 13, 2008
    Decision Date
    May 13, 2008
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, Implanted

    Similar 510(k) Clearances

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

    Hemodialysis Catheter

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

    End Cap

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

    GlidePath Retro Long-Term Hemodialysis Catheter

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

    GlidePath 13F Long-Term Hemodialysis Catheter

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

    Pristine Long-Term Hemodialysis Catheter

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

    GlidePath 7.5F Long-Term Dialysis Catheter

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

    Other Clearances by AngioDynamics, Inc.

    K Number Device Name
    K252509 AlphaVac Multipurpose Mechanical Aspiration System F1885
    K253106 AngioVac Cannula
    K242687 NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
    K240397 AlphaVac MMA F1885 System (H787253020)
    K231945 VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
    K223581 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K221883 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K213388 AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
    K213067 Solero Microwave Tissue Ablation (MTA) System and Accessories
    K212386 AngioVac F18 85
    Search all 87 clearances from AngioDynamics, Inc. →