Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K993592
    Device Name
    AXIOM MULTIPURPOSE WOUND DRAIN
    Manufacturer
    AXIOM MEDICAL, INC.
    Date Cleared
    2000-05-17

    (208 days)

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

    AXIOM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain.
    Device Description
    This Axiom Multipurpose Wound Drain is simplicity of design assures effective operation with added convenience. It is a conveniently sized double Lumens Catheter made of silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 14 Fr. up to 36 Fr. coated or no coated will be offered. The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first proximal end and connected with polypropylene Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.
    Ask a Question
    K Number
    K971851
    Device Name
    INTERPLEURAL ANESTHESIA CATHETER
    Manufacturer
    AXIOM MEDICAL, INC.
    Date Cleared
    1998-01-22

    (247 days)

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

    AXIOM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Typical applications include: For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.
    Device Description
    This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. The sterile single patient use component includes the following: 2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered. 2.2 The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function). 2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.
    Ask a Question
    K Number
    K965146
    Device Name
    FLAT CLOSED WOUND DRAIN WITH TROCAR
    Manufacturer
    AXIOM MEDICAL, INC.
    Date Cleared
    1997-03-10

    (77 days)

    Product Code
    GBX
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIOM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To drainage excessive body fluid away from the wound site in the Surgery or after Surgery
    Device Description
    This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following: Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered. Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered. Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.
    Ask a Question

    Page 1 of 1