K-number	K171081
Device name	Guider Catheter Introducer
Applicant	Rhythm Xience, Inc. (Rxi)
Product code	DYB
Device class	Class II
Decision date	May 9, 2017
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Guider Catheter Introducer

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