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Home » Gore Gets 510(k) Clearance of Molding and Occlusion Balloon
Gore Gets 510(k) Clearance of Molding and Occlusion Balloon
![ClearanceStamp_Orange.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Orange.gif?t=1609798625&width=430)
August 23, 2018
The FDA cleared Gore’s molding and occlusion balloon device, a compliant polyurethane balloon catheter.
The device meets all endovascular aortic repair procedural requirements, from 10 to 37 mm device sizes, and consists of a single balloon, removing the need for multiple molding and occlusion balloons.
It comes in a single catheter length of 90 mm for use with Gore Excluder devices and is designed to help clinicians with the expansion of self-expanding stent grafts and the temporary occlusion of large-diameter vessels. It is also compatible with 108 cm length guidewire.
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