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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 25 Results
510(K) Number: K000729
 
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UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow® IAB is utilized for intra aortic ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow® IAB is utilized for intra aortic ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow® IAB is utilized for intra aortic ball... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow® IAB is utilized for intra aortic ball... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow® IAB is utilized for intra aortic ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS 1 12/23/2010 Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS 1 12/23/2010 Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U 1 12/23/2010 Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U 1 12/23/2010 Arrow International, Inc., Division of Teleflex Medical Inc.
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model:... 1 12/23/2010 Arrow International, Inc., Division of Teleflex Medical Inc.
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