Name: Predicase
Price: 199 USD

K-number	K233708
Device name	NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Applicant	Synaptic Medical Corporation
Product code	DYB
Device class	Class II
Decision date	Feb 16, 2024
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

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