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510(k) Data Aggregation

    K Number
    K250962
    Device Name
    APRO 55 Intermediate Catheter
    Manufacturer
    Alembic, LLC
    Date Cleared
    2025-04-29

    (29 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K243297,K234115
    Why did this record match?
    Reference Devices :

    K243297

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

    The APRO 55 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

    Device Description

    The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.

    AI/ML Overview

    The FDA 510(k) clearance letter for the APRO 55 Intermediate Catheter (K250962) indicates that this is a catheter device, not an AI/Software as a Medical Device (SaMD).

    Therefore, the requested information regarding acceptance criteria, study design, expert consensus, ground truth, and training data, which are typical for SaMD or AI-based medical devices, are not applicable to this submission.

    The clearance is based on the device being substantially equivalent to a predicate device (APRO® 55 Catheter, K234115) with the only difference being in the packaging configuration. The substantial equivalence is supported by non-clinical testing, specifically bench testing for sterility and shelf-life, and a justification for not requiring new biocompatibility testing (due to material and processing similarity to previously cleared devices).

    In summary, there is no AI component or related clinical performance study described in this document that would necessitate the details requested in your prompt.

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