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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K133265
Device Name QUADROX-IR ADULT AND SMALL ADULT
Applicant
Maquet Cardiopulmonary, AG
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
Maquet Cardiopulmonary, AG
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact WHITNEY TORNING
Regulation Number870.4360
Classification Product Code
KFM  
Subsequent Product Codes
DTM   DTR   DTZ  
Date Received10/23/2013
Decision Date 11/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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