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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: DTZ Applicant: TERUMO CARDIOVASCULAR SYSTEMS CORP. Decision Date To: 06/01/2024
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terumo capiox sx18 oxygenator/ hardshell reservoir, terumo capiox sx18 oxygenator/ hardshell reservoir with xcoating, terumo capiox sx25 oxygenator/hardshell reservoir, terumo capiox sx25 oxygenator/hardshell reservoir with xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP. K153140 12/02/2015
capiox sx18 hollow fiber oxygenator with detachable hardshell reservoir, capiox sx25 hollow fiber oxgenator with detacha TERUMO CARDIOVASCULAR SYSTEMS CORP. K130359 03/13/2013
capix rx hollow fiber oxygenator with/without hardshell reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K130333 03/13/2013
capiox rx oxygenator with or without reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K062381 08/24/2006
capiox rx15 hollow, fiber oxygenator with/without hardshell reservoir TERUMO CARDIOVASCULAR SYSTEMS CORP. K051997 09/15/2005
capiox sx10 hollow fiber oxygenator with/without hardshell reservoir with x-coating TERUMO CARDIOVASCULAR SYSTEMS CORP. K010443 12/11/2001
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