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FDA 510(k)

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

K-Number: K193548 · 2020-01-18

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2020-01-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2020-01-18 under 510(k) number K193548. 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 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire?

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire is a medical device that received FDA 510(k) clearance on 2020-01-18. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K193548.

When did Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire receive FDA 510(k) clearance?

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire received FDA 510(k) clearance on 2020-01-18, under 510(k) number K193548.

Who is the listed applicant for Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire?

The FDA product code for Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire 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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