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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 251 Results
ProductCode: dtz Decision Date From: 1%2F1%2F1965 Decision Date To: 1%2F1%2F2015
 
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d100 kids; d101 kids Sorin Group Italia S.R.L. K231652 11/16/2023
quantum perfusion blood oxygenator with integrated af and sensor vt75-c1u, quantum perfusion blood oxygenator with integrated af vt75-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion b Qura S.r.l. K231773 11/08/2023
cmo8 adult pmp oxygenator with tubing pack (model: cme40009) Chalice Medical Ltd K231414 11/01/2023
affinity fusion™ oxygenator system Medtronic Inc. K230640 04/06/2023
oxy-1 system Abiomed Inc. K223161 02/23/2023
centrimag pre-connected pack Abbott K222297 12/01/2022
quantum perfusion blood oxygenator with integrated af and sensor vt200-c1u, quantum perfusion blood oxygenator with integrated af vt200-c2u, quantum perfusion blood oxygenator with integrated af and sensor vt160-c1u,quantum perfusion blood oxygenator with integrated af vt160-c2u Qura S.r.l. K212341 01/28/2022
quantum perfusion blood oxygenator ecc vt200-e1, quantum perfusion blood oxygenator ecc vt200-e2, quantum perfusion blood oxygenator ecc vt160-e1, quantum perfusion blood oxygenator ecc vt160-e2 Qura S.r.l. K203424 12/17/2021
amg pmp infant Eurosets S.r.l. K202510 12/10/2021
affinity fusion oxygenator system, affinity pixie oxygenation system Medtronic K203111 09/16/2021
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