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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K190634
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STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO 2 08/28/2021 FEI # 3004742232
Cardiovascular Systems Inc
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 2 08/28/2021 FEI # 3004742232
Cardiovascular Systems Inc
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