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Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

K181042 Class II Special
Decision Date
2018-05-17
Sponsor / Applicant
Boston Scientific Corporation

Technical Specification

510(k) Submission ID K181042
Product Code DXK
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2330
Decision Date 2018-05-17
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter received FDA 510(k) clearance under submission number K181042, sponsored by Boston Scientific Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-05-17.

Classification & Regulation

This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.