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510(k) K160173

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) by Boston Scientific Corporation — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2016
Date Received
January 27, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

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