K-number	K181031
Device name	TSI Transseptal Introducer
Applicant	Pressure Products Medical Device Manufacturing, LLC
Product code	DYB
Device class	Class II
Decision date	Oct 26, 2018
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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TSI Transseptal Introducer

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