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510(k) Data Aggregation

    K Number
    K220604
    Device Name
    EXTesia Introducer Sheath Set
    Date Cleared
    2022-04-27

    (56 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Curatia Medical Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.
    Device Description
    The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.
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    K Number
    K180797
    Device Name
    Xcess Guiding Catheter
    Date Cleared
    2018-12-14

    (262 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Curatia Medical Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
    Device Description
    The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.
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