K-number	K240246
Device name	Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Applicant	Synaptic Medical Corporation
Product code	DRC
Device class	Class II
Decision date	Jul 26, 2024
Decision	Substantially Equivalent
Regulation	870.1390

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Source

View the full FDA submission: accessdata.fda.gov

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Accusafe Transseptal Guidewire (GTR31180, GTR31230)

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