FDA 510(k) Applications for Medical Device Product Code: DXK (Echocardiograph)

FDA 510(k) Applications for Medical Device Product Code "DXK"
(Echocardiograph)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K160173	Boston Scientific Corporation	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)	02/26/2016
K181042	Boston Scientific Corporation	Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter	05/17/2018
K031148	JOMED, INC.	IN-VISION IMAGING SYSTEM	05/28/2003