Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251422
    Date Cleared
    2025-10-08

    (154 days)

    Product Code
    Regulation Number
    880.5200
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BD Saf-T-Intima™ Subcutaneous Catheter System is intended to be inserted into a patient's subcutaneous tissue for short term use for the administration of fluids and medications. This device is also intended to be inserted into a patient's peripheral venous system for short term use to administer fluids or sample blood. This device may be used for any patient population with consideration given to adequacy of subcutaneous tissue or vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

    Device Description

    BD Saf-T-Intima™ Subcutaneous Catheter System is an over-the-needle subcutaneous and intravenous (IV) catheter. This device includes a radiopaque BD Vialon™ Catheter Material, a needle attached to a wire stylet, wings for insertion assistance and catheter securement, integrated extension tubing, a clamp, a single or dual port, a BD ® PRN Adapter, vent plug (dual port only), and a needle shield. The needle and catheter are protected by a needle cover.

    BD Saf-T-Intima™ Subcutaneous Catheter System is designed to keep blood contained within the device throughout the insertion process. The needle is passively protected when it is removed, reducing the risk of accidental needlestick injury. Both the wings and single port or dual port are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1