K-number	K230704
Device name	RAIN Sheath Tibial Pedal Introducer
Applicant	Cordis US Corp
Product code	DYB
Device class	Class II
Decision date	Apr 24, 2023
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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RAIN Sheath Tibial Pedal Introducer

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RAIN Sheath Tibial Pedal Introducer