K-number	K230376
Device name	Reprocessed Agilis NxT Steerable Introducer
Applicant	Innovative Health, LLC
Product code	PNE
Device class	Class II
Decision date	Aug 7, 2023
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Agilis NxT Steerable Introducer

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