CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 65 cm

Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10.

Cardiovascular Devices

2

No

Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.

EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards || Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. || Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows || delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.