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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K212959
Device Name ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
Applicant
Siemens Medical Solutions USA, Inc.
22010 SE 51st St.
Issaquah,  WA  98029
Applicant Contact HyunJung Lee
Correspondent
Siemens Medical Solutions USA, Inc.
22010 SE 51st St.
Issaquah,  WA  98029
Correspondent Contact HyunJung Lee
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received09/16/2021
Decision Date 10/15/2021
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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