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Mirage Hydrophilic Guidewire Model 103-0608
Product: MirageTM — all models and sizes
Summary: The Mirage Hydrophilic Guidewire is a medical device used to navigate through blood vessels during procedures such as embolization. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002212 ↗
Decision Date ?
August 3, 2000
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Mirage Hydrophilic Guidewire, manufactured by Micro Therapeutics, was cleared by the FDA via the 510k pathway on August 3, 2000. It is a Class 2 device under product code DQX.
What It Is
The Mirage Hydrophilic Guidewire is a flexible, steerable wire with a hydrophilic coating that reduces friction, facilitating smooth navigation through the vascular system. It is designed to assist in the placement of catheters and other devices during minimally invasive procedures. The hydrophilic coating helps in traversing tortuous vessels and crossing lesions with ease.
FDA-Cleared Indications
- Use as a guidewire to facilitate the placement and navigation of catheters within blood vessels during diagnostic and interventional procedures.
- Use in vascular procedures requiring catheter advancement through challenging or tortuous anatomy, including embolization procedures.
Clinical Applications
- Guiding catheters during vascular embolization procedures.
- Facilitating catheter placement during diagnostic angiography.
- Helping navigate tortuous or anatomically difficult blood vessels during catheter-based interventions.
- Supporting advancement of compatible catheters and interventional devices through the vascular system.
Practical Considerations
- The hydrophilic coating requires wetting and appropriate handling according to the device labeling; a lubricious wire can move easily and should be controlled under fluoroscopic guidance.
- Confirm compatibility among the guidewire, catheter, introducer sheath and other devices before use, including the required inner diameter and guidewire length.
- Available size, length and tip configurations should be matched to the target vessel and procedure; the specific Model 103-0608 specifications should be verified in the current manufacturer labeling.
- Do not advance or withdraw the wire against significant resistance. Excessive force, sharp bends or repeated manipulation can contribute to vessel injury or device damage.
- MRI safety status should not be assumed from the FDA clearance record. Check the current manufacturer labeling for MRI compatibility or conditional-use requirements before MRI exposure.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Mirage Hydrophilic Guidewire used for?
It is used to navigate through blood vessels during procedures like embolization, aiding in the placement of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in navigating blood vessels during minimally invasive procedures such as embolization.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.