www.fdanews.com/articles/67303-haemonetics-gets-fda-clearance-for-cardiopat
HAEMONETICS GETS FDA CLEARANCE FOR CARDIOPAT
January 7, 2005
Medical device company Haemonetics has reported the FDA cleared its CardioPAT surgical blood salvage system.
The CardioPAT system recovers blood lost during and after heart surgery and makes it available for transfusion back into the patient. The device broadens the company's blood recovery line by allowing surgeons to use the device during off pump, or beating heart, cardiovascular surgery.
The product was cleared though the agency's 510(k) program for products that already have equivalents on the market. Haemonetics said it expects to launch the product fully sometime this year and will start using the device in customer acceptance trials at three U.S. sites immediately.