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510(k) Data Aggregation

    K Number
    K101982
    Device Name
    MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
    Manufacturer
    ST JUDE MEDICAL, CRMD
    Date Cleared
    2010-12-21

    (160 days)

    Product Code
    DTA
    Regulation Number
    870.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ST JUDE MEDICAL, CRMD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merlin PSA Patient Cable EX3150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-1 leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3170 Cable Adapter can connect to the Models 4051/4051A disposable patient cables for IS-1 leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads. The Merlin PSA "M" Adapter Model EX3180 is intended to connect the Merlin PSA to the twochannel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads. Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.
    Device Description
    The Merlin PSA Patient cable, Model EX3150 is an accessory to the Merlin PSA EX3100 system, which is intended to assess the pacing and sensing performance of the lead system prior to pulse generator implantation, or during invasive lead system troubleshooting. The PSA Patient cable is intended to connect one to three implanted leads to the Merlin PSA EX3100, which is the patient interface part of the PSA product. The PSA Patient cable is the interface between the implanted leads and the PSA unit. The ODU connector end of the cable is connected to the Merlin PSA and the Alligator clip end is connected to the leads. The PSA Patient cable is re-sterilizable. Patient Cable Adapters - Merlin PSA Cable Adapter EX 3170, Merlin PSA "M" Adapter EX 3180 connects the Merlin PSA to commonly used PSA patient cables Merlin PSA Cable Adapter EX3170 connects to the currently marketed disposable surgical cables 4051/4051A and 4161. Merlin PSA "M" Adapter EX3180 connects to the Medtronic Model 2292 patient cable.
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