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Found 3 results
510(k) Data Aggregation
K Number
K030852Device Name
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
Manufacturer
MOGUL ENTERPRISES
Date Cleared
2003-07-10
(114 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
MOGUL ENTERPRISES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified device has the same intended use as that of the FDA-cleared (unmodified) device, which is as follows: "The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study."
Device Description
Not Found
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K Number
K011734Device Name
6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
Manufacturer
MOGUL ENTERPRISES
Date Cleared
2001-07-03
(28 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
MOGUL ENTERPRISES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Catheter is intended for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
Device Description
6-French 20-Electrode Electrophysiology Diagnostic Catheter
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K Number
K993698Device Name
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
Manufacturer
MOGUL ENTERPRISES
Date Cleared
2000-08-16
(288 days)
Product Code
DRF
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
MOGUL ENTERPRISES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.
Device Description
Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter
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