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510(k) Data Aggregation
K Number
K151139Device Name
EasyMap MAP Catheter
Manufacturer
Date Cleared
2016-10-18
(538 days)
Product Code
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
MedFact Engineering GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EasyMap MAP catheters are indicated for simultaneously pacing and recording Monophasic Action Potentials (MAPs) from the endocardial surface of the human heart.
Device Description
EasyMap MAP is a single-use disposable quadropolar catheter for recording monophasic action potentials and for intracardial pacing. Integrated in the catheter tip are a Silver-Chloride Electrode (AgCI), a Silver Electrode (Ag) and two orthogonally placed Silver Electrodes (Ag). These electrodes enable mapping of cardiac electrochemical potentials. The catheter tip can be deflected in a single direction up to 270 degrees.
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