510(k) K191687

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire by Phenox Limited — Product Code DQX

K191687 is an FDA 510(k) premarket notification submitted by Phenox Limited for the device "pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire". The FDA issued a decision of Substantially Equivalent on October 9, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Phenox Limited has at least 3 other 510(k) clearances on record.