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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K230698
Device Name Anivia SG1000 Pump Console
Applicant
Apmtd, Inc.
226 Lowell St.
Unit B16
Wilmington,  MA  01887
Applicant Contact John Sasso
Correspondent
Apmtd, Inc.
226 Lowell St.
Unit B16
Wilmington,  MA  01887
Correspondent Contact John Sasso
Regulation Number870.4380
Classification Product Code
DWA  
Date Received03/13/2023
Decision Date 04/18/2023
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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