Pryor Medical Gets 510k Clearance for Catheter
Pryor Medical Devices has received 510k clearance from the FDA for its ER-REBOA (resuscitative endovascular balloon occlusion of the aorta) catheter used to temporarily occlude large vessels using a balloon.
The company says the catheter’s key features include its small size because it does not require additional surgical repair at the access site. It also has a soft, atraumatic tip that provides simultaneous arterial pressure monitoring.
Pryor says the catheter is designed specifically for trauma, critical care and emergency medicine.
The company expects first delivery of the catheters by the beginning of 2016. — John Bechtel