BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Geomed Vascular Dilators

    K Number: K183438 · Decision Sep 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    265

    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
    Geomed Vascular Dilators
    K Number
    K183438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4475
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geomed Medizin-Technik GmbH & Co.
    Date Received
    December 12, 2018
    Decision Date
    September 3, 2019
    Product Code
    DWP
    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
    DWP Dilator, Vessel, Surgical

    Similar 510(k) Clearances

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

    SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vessel Dilator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASCULAR PROBE, VASCULAR PROBE ES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RDI CARDIAC INSULATION PAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Geomed Medizin-Technik GmbH & Co.

    K Number Device Name
    K052745 ASSISTO ARM SYSTEMS