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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 the device name listed in this FDA 510(k) record. The listed applicant is Phenox Limited. It received FDA 510(k) clearance on 2019-10-09 under 510(k) 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. The listed applicant is Phenox Limited. The 510(k) number is K191687.

When did pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire receive FDA 510(k) clearance?

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

Who is the listed applicant for pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire?

The FDA 510(k) record lists Phenox Limited as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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