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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 24 Results
510(K) Number: K021462
 
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FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow® IAB is utilized for intra aortic balloon counterpulsa... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow® IAB is utilized for intr... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS 2 03/10/2015 Arrow International Inc
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The A... 2 03/02/2015 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 International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 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.
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