K-number	K221390
Device name	BNLE Access Guidewire
Applicant	Biomerics Nle
Product code	DQX
Device class	Class II
Decision date	Apr 28, 2023
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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BNLE Access Guidewire

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