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510(k) Data Aggregation

    K Number
    K112562
    Device Name
    BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
    Manufacturer
    KIMBERLY-CLARK
    Date Cleared
    2011-12-15

    (80 days)

    Product Code
    OYI
    Regulation Number
    868.6810
    Why did this record match?
    Product Code :

    OYI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.
    Device Description
    Sterile, single use, catheter kit for performing non-bronchoscopic Brochoalveolar Lavage (BAL) in adult patients undergoing mechanical ventilation. (also known as mini-BAL)
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