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

    AngioVac C20, AngioVac C180

    K Number: K190594 · Decision Jul 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    87
    Review Days
    120

    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
    AngioVac C20, AngioVac C180
    K Number
    K190594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AngioDynamics, Inc.
    Date Received
    March 7, 2019
    Decision Date
    July 5, 2019
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    Similar 510(k) Clearances

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

    Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Venous Return Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Retrograde Coronary Sinus Perfusion Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dual Stage Venous Cannulae

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Clearview Intracoronary Shunts

    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. →