K-number	K191687
Device name	pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Applicant	Phenox Limited
Product code	DQX
Device class	Class II
Decision date	Oct 9, 2019
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

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