Name: Predicase
Price: 199 USD

K-number	K160173
Device name	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
Device class	Class II
Decision date	Feb 26, 2016
Decision	Substantially Equivalent
Regulation	870.2330

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Source

View the full FDA submission: accessdata.fda.gov

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

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