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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 25 Results
510(K) Number: K000729
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9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IA... 1 04/16/2009 Arrow International, Inc.
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic ball... 1 04/16/2009 Arrow International, Inc.
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic ball... 1 04/16/2009 Arrow International, Inc.
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number:... 2 04/06/2013 Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: ... 2 04/06/2013 Arrow International 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.
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS 1 12/23/2010 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.
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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