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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 9 of 9 Results
510(K) Number: K063525
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SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsatio... 2 07/21/2023 Datascope Corp.
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic... 2 04/15/2009 Datascope Corporation
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Ball... 1 06/13/2011 Maquet Datascope Corp - Cardiac Assist Division
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic B... 1 05/21/2014 Maquet Datascope Corp - Cardiac Assist Division
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684... 2 08/21/2020 Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 06... 2 08/21/2020 Datascope Corporation
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascop... 2 01/31/2008 Datascope Corp
CS300 Intra-Aortic Balloon Pump 2 06/21/2010 Datascope Corporation
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for ... 2 02/07/2015 Maquet Datascope Corp - Cardiac Assist Division
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