K-number	K232662
Device name	BNLE Hydrophilic Jacketed Peripheral Guidewire
Applicant	Biomerics Nle
Product code	DQX
Device class	Class II
Decision date	May 14, 2024
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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BNLE Hydrophilic Jacketed Peripheral Guidewire

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