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510(k) Data Aggregation
K Number
K012520Device Name
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
Manufacturer
Date Cleared
2002-03-27
(233 days)
Product Code
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC ASSIST DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.
Device Description
The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.
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K Number
K960849Device Name
MAGNO ALARM
Manufacturer
Date Cleared
1997-03-26
(400 days)
Product Code
Regulation Number
870.3690Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC ASSIST DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
Device Description
a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
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K Number
K955847Device Name
GYRO TIP EP CATHETER
Manufacturer
Date Cleared
1997-01-29
(400 days)
Product Code
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC ASSIST DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Monitor and record intra-cardiac electrical activities
Device Description
Not Found
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