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510(k) K163560

Reprocessed AcuNav Diagnostic Ultrasound Catheter by Innovative Health, LLC — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2017
Date Received
December 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reprocessed Intravascular Ultrasound Catheter
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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