Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252677
    Date Cleared
    2025-11-05

    (72 days)

    Product Code
    Regulation Number
    880.5200
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K230616

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Polyshield Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

    Device Description

    The Polyshield Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths, in both with and without wings on the catheter hub.

    Polyshield: An over-the-needle, peripheral active safety IV catheter that incorporates a spring-activated needle shield to help prevent needle-stick injuries

    Polyshield Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a spring-activated needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.

    Polyshield BC: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made.

    Polyshield BC Adva: An over-the-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle). Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.

    Color-coding of the catheter hub (and wings, where fitted) is used to help identify the catheter gauge size, in accordance with ISO 10555-5.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1