The U.S. Food and Drug Administration (FDA) has cleared Alliance Medical Corporation's (Alliance) 510(k) for reprocessed diagnostic electrophysiology (EP) catheters manufactured by Bard, Cordis Webster, Daig, EP Technologies and Medtronic. Alliance has now received clearances on all 20 of the initial premarket notifications [510(k)s] the company submitted to the FDA by the original August 2001 deadline.
"Receiving FDA clearance on our 510(k) for reprocessed diagnostic EP catheters is an important milestone for Alliance and preserves an important cost savings opportunity for our customers. Diagnostic EP catheters were one of the first reprocessed single-use medical devices and hospitals -- many of them struggling financially -- now rely on the savings generated through reprocessing these expensive devices," said Alliance CEO Rick Ferreira.
Alliance is currently preparing additional 510(k)s for new devices and manufacturers as well as extensions to cleared 510(k)s to add more device model numbers.