K-number	K171601
Device name	Ultraxx Nephrostomy Balloon Catheter
Applicant	Cook Incorporated
Product code	LJE
Device class	Class U
Decision date	Feb 23, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Ultraxx Nephrostomy Balloon Catheter

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