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510(k) Data Aggregation
K Number
K012089Device Name
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
Manufacturer
CATHEFFECTS, LLC.
Date Cleared
2002-01-28
(207 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
CATHEFFECTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
Device Description
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K Number
K011361Device Name
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
Manufacturer
CATHEFFECTS, LLC.
Date Cleared
2001-09-06
(126 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
CATHEFFECTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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