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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K223161
Device Name OXY-1 System
Applicant
Abiomed Inc.
22 Cherry Hill Drive
Danvers,  MA  01923
Applicant Contact Ken Ryder
Correspondent
Abiomed Inc.
22 Cherry Hill Drive
Danvers,  MA  01923
Correspondent Contact Ken Ryder
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DWA   DWF   KFM  
Date Received10/07/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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