Name: Predicase
Price: 199 USD

K-number	K173063
Device name	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Applicant	Acist Medical Systems, Inc.
Product code	OBJ
Device class	Class II
Decision date	Oct 23, 2017
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Everything you need for a 510(k) submission. Nothing you don't.