LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K260626

    Validate with FDA (Live)

    Device Name
    Multiflex Steerable Sheath 17.5F
    Manufacturer
    Vizaramed, Inc.
    Date Cleared
    2026-03-26

    (28 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K203670,K221655
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VIZARAMED Multiflex Steerable Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    Device Description

    The Vizaramed Multiflex Steerable Sheath is a deflectable, sterile, single-use, percutaneous steerable sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    The 17.5F sheath is a steerable shaft capable of complex three-dimensional shapes, a handle with lockable steering controls, a Tuohy-Borst adapter with a hemostasis valve, a side port with 3-way stopcock, and atraumatic soft distal tip. The shaft is radio-opaque for easy visualization under fluoroscopy. The accompanying dilator is packaged with the sheath in a pouch for easy removal.

    The 17.5F sheath can accommodate devices of 3F(0.039") - 17.5F (0.230").

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1