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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 K170263
Device Name AcuNav Diagnostic Ultrasound Catheter 8F,10F
Applicant
Siemens Medical Solutions USA, Inc.
685 E. Middlefield Rd.
Moutain View,  CA  94043
Applicant Contact Shelly Pearce
Correspondent
Siemens Medical Solutions USA, Inc.
685 E. Middlefield Rd.
Moutain View,  CA  94043
Correspondent Contact Shelly Pearce
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received01/27/2017
Decision Date 06/15/2017
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
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