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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K200030
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The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten... 2 02/22/2022 BALT USA, LLC
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0... 2 06/18/2025 BALT USA, LLC
Optima Coil System Model OPTI0520CSF10. For endovascular embolization. 2 09/06/2022 BALT USA, LLC
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovasc... 2 10/20/2022 BALT USA, LLC
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are ins... 2 02/08/2024 BALT USA, LLC
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