K160173

Substantially Equivalent

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Applicant: Boston Scientific Corporation
Product code: DXK
Advisory panel: Cardiovascular
Date received: 2016-01-27
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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