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510(k) Data Aggregation
K Number
K133853Device Name
VIEWFLEX XTRA ICE CATHETER
Manufacturer
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY
Date Cleared
2014-05-19
(151 days)
Product Code
OBJ
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
IRVINE BIOMEDICAL, INC. 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 is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
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