# K191687: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

- Pathway: 510(k) (Traditional)
- Applicant: Phenox Limited
- Decided: Oct 9, 2019 after 107 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953533 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093397: Traxcess 14EX Guidewire and Traxcess Docking Wire, MicroVention, Inc. (2009) Summary page 4.
- K934122: Scimed Transend EX Steerable Guide Wire and Accessories, Scimed Peripheral Interventions (1993) Summary page 4.

## Indications for use
The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

Source page: https://510kreport.com/device/K191687
Methodology: https://510kreport.com/methodology