K-number	K212165
Device name	Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
Applicant	Innovative Health, LLC
Product code	PNE
Device class	Class II
Decision date	Mar 10, 2022
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Carto Vizigo Bi-Directional Guiding Sheath

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