K-number	K192289
Device name	IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Applicant	Irras USA, Ltd.
Product code	JXG
Device class	Class II
Decision date	Nov 15, 2019
Decision	Substantially Equivalent
Regulation	882.5550

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View the full FDA submission: accessdata.fda.gov

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IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

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