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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K193482
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TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 2 08/26/2025 FEI # 3038195011
VANTIVE US HEALTHCARE LLC
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 2 08/26/2025 FEI # 3038195011
VANTIVE US HEALTHCARE LLC
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