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FDA 510(k)

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

K-Number: K191687 · 2019-10-09

ApplicantPhenox Limited
Decision Date2019-10-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is a medical device manufactured by Phenox Limited. It received FDA 510(k) clearance on 2019-10-09 under approval number K191687. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Phenox Limited. The 510(k) number is K191687.

When was pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire approved by the FDA?

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire received FDA 510(k) clearance on 2019-10-09, under approval number K191687.

What company makes pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is manufactured by Phenox Limited.

What is the FDA product code for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

The FDA product code for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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