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510(k) K203726

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter by Siemens Medical Solutions USA, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2021
Date Received
December 21, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ultrasound, Intravascular
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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