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510(k) Data Aggregation

    K Number
    K251019

    Validate with FDA (Live)

    Device Name
    BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
    Manufacturer
    Bioteque Corporation
    Date Cleared
    2025-12-22

    (264 days)

    Product Code
    FGE,GBO,LJE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K210419,K200103
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The catheter is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

    Device Description

    The BT-PD1-SERIES-G / BT-PD1-SERIES(MN)-G / BT-PD1-SERIES-G(+FSC) / BT-PDS-SERIES-G / BT-PDS-SERIES(MN)-G / BT-PDS-SERIES(B)-RB-G Percutaneous Drainage Catheter with hydrophilic coating is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or mini-pigtail close loop and drainage holes.

    AI/ML Overview

    N/A

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