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510(k) Data Aggregation
K Number
K223077Device Name
ViewFlex Xtra ICE Catheter
Manufacturer
Irvine Biomedical, a St. Jude Medical Company
Date Cleared
2022-12-07
(68 days)
Product Code
OBJ
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
Irvine Biomedical, a St. Jude Medical Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
Device Description
The ViewFlex™ Xtra ICE Catheter ("ViewFlex™ Catheter") is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.
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