K-number	K170997
Device name	CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Applicant	Biosense Webster, Inc.
Product code	DYB
Device class	Class II
Decision date	Jul 25, 2017
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

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