K-number	K233248
Device name	FARADRIVE Steerable Sheath
Applicant	Boston Scientific Corporation
Product code	DRA
Device class	Class II
Decision date	Dec 11, 2023
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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FARADRIVE Steerable Sheath

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FARADRIVE Steerable Sheath