K-number	K233503
Device name	14F iSLEEVE Introducer Set
Applicant	Boston Scientific Corporation
Product code	DYB
Device class	Class II
Decision date	Nov 30, 2023
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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14F iSLEEVE Introducer Set

Everything you need for a 510(k) submission. Nothing you don't.