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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K132175
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IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, S... 1 06/11/2019 Edwards Lifesciences, LLC
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm)... 2 06/11/2015 Edwards Lifesciences, LLC
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