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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 K173618
Device Name ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
Applicant
Siemens Medical Solutions USA, Inc.
685 E. Middlefield Rd.
Moutain View,  CA  94043
Applicant Contact HyunJung Lee
Correspondent
Siemens Medical Solutions USA, Inc.
685 E. Middlefield Rd.
Moutain View,  CA  94043
Correspondent Contact HyunJung Lee
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received11/22/2017
Decision Date 12/19/2017
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
Recalls CDRH Recalls
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