Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)— 510(k) K160173

Name: FDA 510(k) clearance K160173
Creator: U.S. Food and Drug Administration
Published: 2016-02-26

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K160173 for Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU), Substantially Equivalent on 2016-02-26. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 2016-01-27
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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