K-number	K170671
Device name	SafeSept Transseptal Guidewire
Applicant	Pressure Products Medical Device Manufacturing, LLC
Product code	DRC
Device class	Class II
Decision date	Oct 20, 2017
Decision	Substantially Equivalent
Regulation	870.1390

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Source

View the full FDA submission: accessdata.fda.gov

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SafeSept Transseptal Guidewire

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