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

    ANGIODYNAMICS, INC., MICRO ACCESS KITS

    K Number: K051655 · Decision Sep 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    87
    Review Days
    83

    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., MICRO ACCESS KITS
    K Number
    K051655
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AngioDynamics, Inc.
    Date Received
    June 21, 2005
    Decision Date
    September 12, 2005
    Product Code
    DQR
    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
    DQR Cannula, Catheter

    Similar 510(k) Clearances

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

    INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RMI INTERNAL MAMMARY ARTERY CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED SHILEY FEMORAL VENOUS CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    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. →