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

    Glidesheath Slender

    K Number: K173831 · Decision May 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    14
    Review Days
    141

    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
    Glidesheath Slender
    K Number
    K173831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Medical Corporation
    Date Received
    December 18, 2017
    Decision Date
    May 8, 2018
    Product Code
    DYB
    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
    DYB Introducer, Catheter

    Similar 510(k) Clearances

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

    FieldFlex Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Echo Large Bore Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Introducer Sheath Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath+ introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aventus Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Protaryx Transseptal Puncture Device (PTX2-001)

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

    Other Clearances by Terumo Medical Corporation

    K Number Device Name
    K231044 R2P Navicross
    K213531 TR BAND Radial Compression Device
    K193125 R2P Destination Slender Guiding Sheath
    K181237 Glidesheath Slender Tibial Pedal Kit
    K172995 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
    K171491 R2P Destination Slender Guiding Sheath
    K152173 Glidesheath
    K152525 TR BAND Radial Compression Device
    K151471 Radifocus Glidewire Endoscopic Wire
    K142183 GLIDESHEATH SLENDER
    Search all 14 clearances from Terumo Medical Corporation →