Device typeCoronary optical coherence tomography system catheter: A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.
FDA categoryOptical coherence tomography, intravascular catheter
Device ID00183739000562
Catalog number100-100-00
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Catheter Gauge2.7 French