K-number	K191871
Device name	15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Applicant	Boston Scientific Corporation
Product code	DYB
Device class	Class II
Decision date	Aug 7, 2019
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

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