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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: DTZ Applicant: Terumo Cardiovascular Systems Corporation Decision Date To: 06/01/2024
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terumo capiox nx19 oxygenator with reservoir (east orientation), terumo capiox nx19 oxygenator with reservoir (west orientation), terumo capiox nx19 oxygenator (east orientation), terumo capiox nx19 oxygenator (west orientation) Terumo Cardiovascular Systems Corporation K180950 06/22/2018
terumo capiox nx19 oxygenator with reservoir (east orientation ), terumo capiox nx19 oxygenator with reservoir (west orientation ), terumo capiox nx19 oxygenator (east orientation ), terumo capiox nx19 oxygenator (west orientation) Terumo Cardiovascular Systems Corporation K172071 03/29/2018
capiox rx hollow fiber oxygenator with/without hardshell reservoir Terumo Cardiovascular Systems Corporation K153213 12/03/2015
terumo capiox fx15 advance oxygenator with integrated arterial filter and reservoir, terumo capiox fx25 advance oxygenator with integrated arterial filter and reservoir TERUMO CARDIOVASCULAR SYSTEMS CORPORATION K151791 11/19/2015
terumo capiox fx15 advance oxygenator with integrated arterial filter and hardshell reservoir Terumo Cardiovascular Systems Corporation K151389 10/20/2015
terumo capiox fx15 and fx25 hollow fiber oxygenator/reservoir Terumo Cardiovascular Systems Corporation K140774 06/02/2014
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