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510(k) Data Aggregation
K Number
K103812Device Name
MITRA-LIFT
Manufacturer
Date Cleared
2011-05-18
(140 days)
Product Code
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
SCIENCITY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mitra-Lift is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
Device Description
Mitra-Lift Set is set of devices for mitral annuloplasty. This set consists of Mitra-Lift (implant device for mitral annuloplasty), and its accessories (Sizers and holders). The main device (Mitra-Lift series) is supplied sterile and intended for single use only. Mitra-Lift series is constructed of polyester textile materials and provided as the various sizes. It is intended to be used with its accessories, Mitral Sizer and Holder Handle.
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