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510(k) Data Aggregation

    K Number
    K202226
    Device Name
    Lim Precision Steerable TS, Steerable Sheath, Dilator
    Date Cleared
    2020-12-15

    (130 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Keystone Heart, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LIM Precision Steerable TS Transseptal System is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Keystone Heart LIM Precision Steerable TS Transseptal System is a sterile, single use, tridirectional introducer. The system consists of a sheath and a dilator. The sheath has a handle assembly with a rotating knob and steering lever that deflects the distal end of the sheath. The dilator can be inserted and advanced or retracted through the inner lumen of the sheath. Hemostasis is maintained along the dilator lumen via a hemostatic valve. The dilator lumen is flushable. Once the dilator is generally in the proper position relative to the sheath, an actuator is tightened to secure the dilator to the handle. A knob is then turned to slowly advance the dilator.
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