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Merit Hydrophilic Guide Wire
Summary: The Merit Hydrophilic Guide Wire is a flexible, lubricated guide wire used in various interventional procedures to navigate through vessels or strictures. It is primarily used by interventional radiologists and urologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131710 ↗
Decision Date ?
July 29, 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 July 29, 2013. It is manufactured by Merit Medical Systems and classified as a Class 2 device under product code DQX.
What It Is
The Merit Hydrophilic Guide Wire is a medical device designed to facilitate the navigation of catheters and other devices through tortuous or narrowed vessels. Its hydrophilic coating reduces friction, allowing for smoother passage through challenging anatomical pathways. This guide wire is particularly useful in procedures requiring precise navigation and placement.
FDA-Cleared Indications
- Facilitation of the placement and navigation of catheters and other medical devices during vascular procedures.
- Facilitation of the placement and navigation of catheters and other medical devices during nonvascular procedures.
- Use as a guide wire when access through tortuous, narrowed, or obstructed anatomy is required.
Clinical Applications
- Guiding catheters during diagnostic vascular procedures such as angiography.
- Facilitating device placement during endovascular procedures, including embolization.
- Supporting catheter or device passage through narrowed or tortuous vascular anatomy.
- Guiding devices during nonvascular procedures involving obstructed or narrowed passages, including selected urinary tract interventions.
Practical Considerations
- Available guide-wire diameter and length should match the access route, target anatomy, catheter, and planned procedure.
- The hydrophilic coating becomes highly slippery when wet; maintain control of the wire and follow the product instructions for preparation and handling.
- Use only with compatible catheters and devices, and confirm compatibility before insertion.
- The record identifies a Class II device under FDA product code DQX; MRI safety depends on the specific model, materials, and labeling, so verify the current product-specific MRI information before scanning.
- Potential guide-wire complications include vessel or tissue injury, perforation, dissection, spasm, thrombosis, infection, and loss or fracture of the wire; contraindications and precautions are defined by the current manufacturer labeling and the planned procedure.
Related Literature
The linked study from 1997 explored the use of a hydrophilic coated guide wire in a modified 'through and through' technique to traverse ureteric strictures. Five cases were presented where traditional methods failed, and the hydrophilic guide wire successfully facilitated the procedure. While the study highlights the effectiveness of the technique, it is limited by its small sample size and lack of comparison with newer technologies.
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 through vessels or strictures during interventional procedures, aiding in the placement of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and urologists commonly use this device in procedures involving vascular or urinary systems.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of devices during vascular and non-vascular procedures, particularly in patients with narrowed or obstructed pathways.
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.