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

    Prelude Wave Hydrophilic Sheath Introducer

    K Number: K250909 · Decision Apr 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    49
    Review Days
    30

    Basic Information

    Device Name
    Prelude Wave Hydrophilic Sheath Introducer
    K Number
    K250909
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    March 26, 2025
    Decision Date
    April 25, 2025
    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.

    AuST Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PeriCross™ Epicardial Access Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards eSheath Optima introducer set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    iSLEEVE Introducer Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ViaOne Epicardial Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca

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

    Other Clearances by Merit Medical Systems, Inc.

    K Number Device Name
    K242873 Ventrax™ Delivery System
    K242229 Micro Ace Gold Advanced Micro Access System
    K241521 Prelude Small O.D. Introducer Guide Wire
    K233268 Impress Angiographic Catheter
    K240261 Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
    K233813 Bearing nsPVA Express™
    K230418 Mighty Wire Guide Wire
    K232609 Micro Ace™ Advanced Micro Access System
    K231246 Ventrax™ Delivery System (VTR851)
    K212696 Aspira Pleural Drainage System
    Search all 49 clearances from Merit Medical Systems, Inc. →