BEUDAMED
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    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

    FDA Enforcement
    Class II ·Terminated·Datascope Corp.·November 13, 2019

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·May 28, 2014

    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·March 4, 2015

    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·March 8, 2017

    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·February 18, 2015

    Cardiosave Hybrid and rescue IABP

    FDA Enforcement
    Class II ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·April 6, 2016

    CS 300 Intra-Aortic Balloon Pump

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017

    CS 100 Intra-Aortic Balloon Pump

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017

    CS 100i Intra-Aortic Balloon Pump

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·August 2, 2017