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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 K202169
Device Name Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Applicant
Qura S.R.L
Via Di Mezzo, 23
Mirandola,  IT 41037
Applicant Contact Raffaella Tommasini
Correspondent
Qura S.R.L
Via Di Mezzo, 23
Mirandola,  IT 41037
Correspondent Contact Raffaella Tommasini
Regulation Number870.4360
Classification Product Code
KFM  
Date Received08/03/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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