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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K021462
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Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS 2 03/10/2015 FEI # 3015859709
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 FEI # 3015859709
Arrow International Inc
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow® IAB is utilized for intr... 1 03/11/2016 FEI # 3010532612
Arrow International, Inc., Division of Teleflex Medical Inc.
FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow® IAB is utilized for intra aortic balloon counterpulsa... 1 03/11/2016 FEI # 3010532612
Arrow International, Inc., Division of Teleflex Medical Inc.
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