LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050557
    Device Name
    AMT NANOCATH
    Manufacturer
    AMERICAN MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-05-27

    (85 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT NanoCath™ epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural caudal anesthesia for up to 72 hours
    Device Description
    The AMT NanoCath is comprised of a tightly coiled stainless steel, covered over most of its length with polvethylene terphthalate. The tip of the catheter is welded into a smooth cover to which is welded a safety ribbon of stainless steel. A stylet of stainless with a plastic handle made of delrin or polycarbonate fits inside the catheter. The catheter is available in 19 - 21 gauge, in lengths of 30 to 90 cm. The wire coil has an outer diameter from 0.8 to 1.0 mm. The NanoCath was compared with substantially equivalent devices in fatigue tests and shown equivalent.
    Ask a Question

    Page 1 of 1