K-number	K221846
Device name	Artix Ballon Guiding Sheath
Applicant	Inari Medical
Product code	DQY
Device class	Class II
Decision date	Jul 11, 2022
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Artix Ballon Guiding Sheath

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