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510(k) Data Aggregation

    K Number
    K022287
    Device Name
    3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
    Manufacturer
    3T MEDICAL SYSTEMS, LLC.
    Date Cleared
    2002-09-23

    (70 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    3T MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.
    Device Description
    Not Found
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    K Number
    K020768
    Device Name
    3T VESSEL CANNULAS
    Manufacturer
    3T MEDICAL SYSTEMS, LLC.
    Date Cleared
    2002-08-23

    (169 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    3T MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3T Medical Systems vessel cannulas are indicated for use during open-heart surgery or in vascular surgery to help check for leaks in a harvested vein which will be used for a graft.
    Device Description
    Not Found
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    K Number
    K020365
    Device Name
    3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
    Manufacturer
    3T MEDICAL SYSTEMS, LLC.
    Date Cleared
    2002-05-03

    (88 days)

    Product Code
    KRI
    Regulation Number
    870.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    3T MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.
    Device Description
    Not Found
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    K Number
    K001245
    Device Name
    3T L. V. CONTROL VALVE
    Manufacturer
    3T MEDICAL SYSTEMS, LLC.
    Date Cleared
    2001-08-15

    (484 days)

    Product Code
    MJJ
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    3T MEDICAL SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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