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October 26, 2015
FDA Clears Pryor Medical Catheter
October 26, 2015—Pryor Medical Devices announced it has received US Food and Drug Administration 510(k) clearance for the sale and distribution of its catheter for resuscitative endovascular balloon occlusion of the aorta (REBOA) by trauma, critical care, and emergency medicine specialists. Pryor Medical has scheduled first delivery of its catheters for January 1, 2016. Designed to temporarily occlude large vessels and monitor arterial pressure, the 7-F size precludes the need for additional surgical repair at the access site. In addition, the REBOA device does not require multiple wire exchanges. It also has a soft, atraumatic tip and provides for simultaneous arterial pressure monitoring, stated Pryor Medical.
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