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510(k) Data Aggregation

    K Number
    K101189
    Device Name
    REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
    Manufacturer
    REAVILLMED
    Date Cleared
    2010-12-22

    (238 days)

    Product Code
    DRS, LJS
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REAVILLMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
    Device Description
    The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device: - . Blood pressure monitoring line and end cap - . Disposable pressure transducer - Single lumen polyurethane reverse taper catheter . - . Catheter hub with suture wing tabs and slip tip cap The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line. The product is sold sterile, single use, and non-pyrogenic.
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