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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K211405
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Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 ... 2 06/27/2024 FEI # 1721504
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY 2 05/20/2024 FEI # 1721504
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY 2 05/20/2024 FEI # 1721504
Merit Medical Systems, Inc.
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