4 results
·
39ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
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