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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 32 Results
ProductCode: DTZ Applicant: Medtronic Decision Date To: 06/17/2024
 
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affinity nt oxygenator and uncoated cardiotomy/ venous reservoir (541); affinity nt oxygenator with balance biosurface and uncoated cardiotomy/venous reservoir (541b) Medtronic Inc. K241352 06/12/2024
affinity fusion™ oxygenator system Medtronic Inc. K230640 04/06/2023
affinity fusion oxygenator system, affinity pixie oxygenation system Medtronic K203111 09/16/2021
affinity nt oxygenator with balance biosurface, affinity nt oxygenator with balance biosurface and uncoated cardiotomy/venous reservoir Medtronic, Inc. K191444 09/27/2019
affinity nttm oxygenator (model 511), affinity® nt hollow fiber oxygenator with plasma resistant fiber (prf) with trilliumtm biosurface (model 511t), affinity® nt integrated cvr/membrane oxygenator with plasma resistant fiber (model 541), affinity® nt integrated cvr/membrane oxygenator with plasma Medtronic, Inc. K191029 05/17/2019
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface, affinity nt oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cortiva bioactive surface, affinity fusion oxygenator with balance biosurface Medtronic Inc K183490 04/12/2019
affinity pixie™ oxygenator with balance™ biosurface (model bbp211), affinity pixie™ oxygenator and cardiotomy/venous reservoir with balance™ biosurface (model bbp241), affinity pixie™ oxygenator with cortiva™ bioactive surface (model cbp211), affinity pixie™ oxygenator and cardiotomy/venous reservo Medtronic Inc K183511 03/18/2019
affinity pixie oxygenator with balance biosurface, affinity pixie oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity pixie oxygenator with cortiva bioactive surface, affinity fusion oxygenator with cardiotomy/venous reservoir and cortiva bioactive surface Medtronic, Inc. K172984 11/20/2017
affinity fusion oxygenator with balance biosurface, affinity fusion oxygenator with cardiotomy/venous reservoir and balance biosurface, affinity fusion oxygenator with cortiva biosurface, affinity fusion oxygenator with cortiva bioactive surface & cardiotomy/venous reservoir Medtronic, Inc. K172626 10/25/2017
affinity nt oxygenator, affinity nt oxygenator with trillium biosurface MEDTRONIC, INC. K162896 12/06/2016
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