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510(k) Data Aggregation
K Number
K070011Device Name
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER
Manufacturer
Date Cleared
2007-03-20
(76 days)
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
IRVINE BIOMEDICAL,INC.(IBI)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.
Device Description
The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer. A Inquiry ClearICE catheter is steerable: catheter, 9 Fr (2.97 mm) in diameter, 90 cm to 110 cm insertable length and available in various curve configuration. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to imaging plane) and anterior-posterior (in a plane coincident with the image plane). Bi-directional steering controlled by push/pull handle mechanism and quad-directional steering controlled by a push/pull mechanism and rotating knob. The non-sterile, reusable GE Connector Cable is use to connect IBI InquiryTM ClearICE™ Intracardiac Echocardiography Catheter to the GE Vivid i Ultrasound system. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is used with commercially available GE Connector Cable and Vivid- i Diagnostic Ultrasound System. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable GE Connector Cable & GE Vivi i Ultrasound System.
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