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Merit Hydrophilic Guide Wire
Summary: The Merit Hydrophilic Guide Wire is a medical device used primarily in interventional radiology and urology to navigate through difficult anatomical pathways. It is utilized by clinicians to facilitate the placement of catheters or stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123609 ↗
Decision Date ?
January 16, 2013
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Merit Hydrophilic Guide Wire was cleared through the FDA 510(k) pathway on January 16, 2013. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Merit Hydrophilic Guide Wire is a flexible, coated wire designed to assist in the navigation of vascular and non-vascular pathways. Its hydrophilic coating allows for smooth passage through tortuous or narrow anatomical structures, reducing friction and facilitating the advancement of catheters or other devices. This guide wire is particularly useful in procedures requiring precise navigation through challenging anatomy.
FDA-Cleared Indications
- Intended to facilitate the placement and exchange of catheters or other interventional devices during diagnostic and therapeutic procedures.
- Intended for use in vascular and nonvascular anatomical pathways where guide-wire navigation is required.
- Use is limited to the specific wire configuration, size, and labeling cleared under FDA 510(k) K123609.
Clinical Applications
- Guiding or exchanging catheters during interventional radiology procedures.
- Navigating tortuous or narrow vascular pathways to support catheter placement.
- Supporting access through nonvascular pathways when the selected wire is labeled for that application.
- Assisting device placement during urologic procedures, when compatible with the specific product labeling.
Practical Considerations
- Hydrophilic coatings generally require activation with sterile saline or another solution specified in the instructions for use; the wire should not be advanced dry.
- Available sizes, lengths, tip shapes, and stiffness vary by model. The wire must be matched to the catheter, sheath, and target anatomy.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for advancement, torque, and withdrawal.
- Potential complications include vessel or tissue injury, perforation, dissection, bleeding, infection, thrombosis, embolization, and wire fracture or entrapment.
- MRI safety depends on the exact model and labeling; verify the device's current MRI conditions before scanning. Do not assume all hydrophilic guide wires are MR safe or MR conditional.
Related Literature
The linked study from 1997 explored the use of a hydrophilic coated guide-wire in a modified through and through technique for traversing tight ureteric strictures. Five cases were presented where traditional methods failed, and the guide wire successfully facilitated the passage. The study highlighted the advantages of the hydrophilic coating in reducing resistance and improving procedural success, though it was limited by a small sample size and lack of long-term outcomes.
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 Merit Hydrophilic Guide Wire used for?
It is used to navigate difficult anatomical pathways, facilitating the placement of catheters or stents in procedures such as embolization or treatment of ureteric strictures.
What specialties typically use this device?
Interventional radiologists and urologists commonly use this device in procedures requiring precise navigation through challenging anatomical structures.
What are the FDA-cleared indications?
The guide wire is indicated for use in procedures requiring navigation through difficult anatomical pathways, such as embolization or ureteric stricture treatment.
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.