Ultrasound Catheters

Ascent Healthcare Receives 510(k) Clearance to Reprocess Siemens ACUSON AcuNav Ultrasound Catheter up to Four Times

Published in Drug Law Weekly, May 8th, 2007

Ascent Healthcare Solutions announced that the U.S. Food and Drug Administration (FDA) has increased the number of times that Ascent can reprocess the AcuNav(TM) Ultrasound Catheter from two to up to four times. Covered devices include the 10 French and 8 French models.

The catheters provide electrophysiologists and interventional cardiologists with high- quality images and blood flow information throughout the entire heart for the diagnosis of certain cardiac arrhythmias.

Ascent originally received clearance to reprocess the catheters in March 2005. This expanded FDA clearance to reprocess the AcuNav Ultrasound Catheter up to four times reflects...

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Source: Drug Law Weekly (2007-05-08)

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