Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2020-01-18 under approval 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. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K193548.

When was Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire approved by the FDA?

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

What company makes Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire?

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

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.

Other Devices by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K162539Solitaire 2 Revascularization Device K161152Navien Intracranial Support Catheter K161879Solitaire Platinum Revascularization Device K172448Riptide Aspiration System K171268Reverse 021 Micro Catheter, Reverse 027 Micro Catheter K160641Solitaire Platinum Revascularization Device, 6x40 mm

View all 28 devices →

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

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.

↑