Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252527

    Validate with FDA (Live)

    Date Cleared
    2025-09-10

    (30 days)

    Product Code
    Regulation Number
    870.1342
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

    Device Description

    The Surfacer System is designed to facilitate entry and placement of central venous access catheters within the peripheral vasculature. The Surfacer System is only sold as a kit as Model or Catalog Number 600200 and is comprised of four components: a Workstation for percutaneous access to the femoral vein; a Delivery Instrument which contains a Needle Wire and Needle Guide which is advanced to the supraclavicular space; an Exit Target which provides fluoroscopic guidance to mark the exit point; and an Exit Introducer which is introduced over the needle wire to access the central venous system. The Exit Targets are packaged with the Delivery Instrument. Once the access is obtained and a catheter is in place, the Surfacer System is removed.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1