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Cardica Inc receives 510(k) clearance for both microcutter XCHANGE 30 white cartridge and new material


Thursday, 27 Feb 2014 08:00am EST 

Cardica Inc:Receives 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MicroCutter XCHANGE 30 white cartridge for the stapling of thin tissue for use in multiple open or minimally-invasive surgical procedures for the transection, resection.In addition, Cardica obtained 510(k) clearance for an additional plastic material contained within the MicroCutter XCHANGE 30 blue cartridge for use in medium thickness tissue.This material was submitted as a Special Premarket Notification 510(k) for the MicroCutter XCHANGE 30 device, which received FDA clearance in January 2014. With these clearances received Cardica does not have any other submissions pending at the FDA. 

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19 Dec 2014