pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

About This 510(k) Submission

K191687 is an FDA 510(k) clearance for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Phenox Limited (Galway, IE). The FDA issued a Cleared decision on October 9, 2019, 107 days after receiving the submission on June 24, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.