Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter— 510(k) K181042

Name: FDA 510(k) clearance K181042
Creator: U.S. Food and Drug Administration
Published: 2018-05-17

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K181042 for Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter, Substantially Equivalent on 2018-05-17. 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: 2018-04-19
Decision date: 2018-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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