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

    A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44

    K Number: K991541 · Decision Dec 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    4
    Review Days
    239

    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
    A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
    K Number
    K991541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A-Med Systems, Inc.
    Date Received
    May 3, 1999
    Decision Date
    December 28, 1999
    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 A-Med Systems, Inc.

    K Number Device Name
    K020529 LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
    K013393 HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
    K992592 A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000