K-number	K233904
Device name	ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
Applicant	Acist Medical Systems, Inc.
Product code	DXO
Device class	Class II
Decision date	Jul 17, 2024
Decision	Substantially Equivalent
Regulation	870.2870

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View the full FDA submission: accessdata.fda.gov

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ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

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