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510(k) Data Aggregation

    K Number
    K251357

    Validate with FDA (Live)

    Device Name
    Esperance pHLO Aspiration System
    Manufacturer
    Phenox, Ltd.
    Date Cleared
    2026-01-15

    (260 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K161640,K211697
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    As part of the Esperance pHLO Aspiration System, the Esperance pHLO Aspiration Catheter with a compatible aspiration pump and the Esperance Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

    Device Description

    The device is supplied as a kit consisting of a single Esperance® pHLO Aspiration Catheter, the Esperance Aspiration Tubing Set, and an introducer sheath, which combined comprise the Esperance® pHLO Aspiration System.

    The Esperance® pHLO Aspiration Catheter is single lumen, flexible, variable stiffness composite catheter. A hub is attached to the proximal end, facilitating attachment of accessories, and the passage of devices into the inner lumen of the catheter, and connection to ancillary devices such as a vacuum source. A polymer sleeve is also attached to the hub and provides a gradual reduction in stiffness from the hub to the catheter shaft, in order to act as a strain relief.

    A radiopaque marker is located approximately 0.6mm from the distal end of the catheter to allow visibility under fluoroscopy. Beyond the radiopaque marker comprises the soft atraumatic tip of the catheter. The following components: inner liner(s), braid, coil and polymer jackets are a part of the internal construction of the catheter. The distal 100cm of the catheter's external surface has a hydrophilic coating for increased lubricity during use. The Esperance pHLO Aspiration Catheter is offered with effective lengths of 125cm and 135cm with an outer diameter (OD) of 6F (0.083", 2.1mm) and an inner diameter (ID) of 0.071" (1.8mm).

    The Esperance® pHLO Aspiration System is a non-active, surgically invasive device intended for short term use within the neurovasculature. The finished catheter is supplied sterile in a hoop, pouch and shelf carton configuration complete with an introducer sheath, aspiration tubing, and Directions for Use (DFU).

    AI/ML Overview

    N/A

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