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510(k) Data Aggregation

    K Number
    K212328
    Device Name
    DiscCath Needle Set
    Manufacturer
    Date Cleared
    2021-09-26

    (61 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    DiscCath LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids. The device is intended for adult patients.
    Device Description
    The DiscCath Needle Set is a single-use intradiscal injection needle comprised of a 17 gauge x 6" Introducer Needle and a 21 gauge x 10.2 inch (nominal) Injection Catheter. The Introducer Needle is comprised of a stainless-steel cannula and metal hub with a stainless-steel stylet with metal hub. The Introducer Needle has a cannula and stylet match ground bevel point at the distal tip which allows for penetration into the intervertebral disc. The Injection Catheter is comprised of a nitinol shape-set tube and a molded plastic hub. The injection catheter tubing is flexible with a curved tip welded closed at the distal end and includes a laser cut side-hole that allows for the injection of a fluid. When used as intended, the Introducer Needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the Introducer Needle stylet, the curved catheter is then inserted through the Introducer Needle cannula and slowly advanced to the target anatomy. The DiscCath Needle Set is sterilized by ethylene oxide and intended for single use.
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