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News Breaks
February 27, 2014
08:07 EDTCRDCCardica receives 510k clearance for MicroCutter XCHANGE
Cardica announced it received 510k clearance from the 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 and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix. In addition, Cardica obtained 510k 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 510k 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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October 22, 2014
17:33 EDTCRDCCardica issues statement regarding Broadfin board nominations
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