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510(k) Data Aggregation
K Number
K060954Device Name
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
Manufacturer
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS
Date Cleared
2006-04-21
(14 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnSite System is indicated for patients for whom electrophysiology studies are indicated.
When used with the EnSite* Catheter, the EnSite System is intended to be used in . the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with the EnSite NavX™ Surface Electrode Kit, the EnSite System is . intended to display the position of conventional electrophysiology catheters in the heart.
Device Description
The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit.
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