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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K133074
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Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter 2 09/08/2022 Datascope Corporation
SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK® Product Code/... 2 10/11/2018 Datascope Corporation
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter puls... 2 07/21/2023 Datascope Corp.
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation ther... 2 07/21/2023 Datascope Corp.
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter 2 09/08/2022 Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and a... 2 04/16/2018 Datascope Corporation
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter 2 09/08/2022 Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01,... 2 08/21/2020 Datascope Corporation
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