K-number	K190473
Device name	ACIST RXi System and Navvus II Catheter
Applicant	Acist Medical Systems, Inc.
Product code	OBI
Device class	Class II
Decision date	Sep 13, 2019
Decision	Substantially Equivalent
Regulation	870.1200

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View the full FDA submission: accessdata.fda.gov

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ACIST RXi System and Navvus II Catheter

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