K-number	K203459
Device name	SafeCross Transseptal Puncture and Introducer (TSP/I) System
Applicant	East End Medical I, LLC
Product code	DYB
Device class	Class II
Decision date	Jul 6, 2021
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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SafeCross Transseptal Puncture and Introducer (TSP/I) System

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