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Datascope Corporation

FDA Regulatory Profile

Summary

Total Recalls
67
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1686-2022Class IISensation Plus 8Fr 50cc Intra-Aortic Balloon CatheterAugust 5, 2022
Z-1687-2022Class IIInsertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon CatheterAugust 5, 2022
Z-0131-2023Class IILINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon cathAugust 5, 2022
Z-1685-2022Class IIMEGA 8Fr 50cc Intra-Aortic Balloon CatheterAugust 5, 2022
Z-2835-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684July 27, 2020
Z-2832-2020Class IIDatascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-0July 27, 2020
Z-2836-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-July 27, 2020
Z-2841-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-July 27, 2020
Z-2840-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684July 27, 2020
Z-2842-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: IndicJuly 27, 2020
Z-2846-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00July 27, 2020
Z-2838-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 068July 27, 2020
Z-2833-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0July 27, 2020
Z-2847-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00July 27, 2020
Z-2839-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-July 27, 2020
Z-2831-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-July 27, 2020
Z-2845-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00July 27, 2020
Z-2843-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-0July 27, 2020
Z-2837-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01,July 27, 2020
Z-2844-2020Class IIDatascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-0July 27, 2020