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Medical Devices / Submissions and Approvals

FDA Clears SurModics’ Sublime Sheath

April 24, 2019

The FDA granted 510(k) clearance to SurModics’ Sublime guide sheath, a radial artery access device for use in coronary procedures.

Designed for kink resistance and strength, the flexible braid-reinforced device has a working length covered in hydrophilic coating, creating a lubricious surface. It includes a dilator and hemostasis valve with a side arm for flushing.

The device will be available in two lengths (120 and 150 centimeters) and two diameters (five and six French gage).

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