đź“‹ FDA Reference
merit hydrophilic guide wire
Merit Medical Systems
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
510K
Number
K123609 ↗
Decision Date
January 16, 2013
Product Code
DQX
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.
Clinical Applications
This guide wire is commonly used in interventional radiology and urology, particularly in procedures involving the placement of catheters or stents in narrow or obstructed pathways. It is often employed in the treatment of ureteric strictures or other conditions where traditional methods may fail. The device is suitable for use in both hospital and outpatient settings, catering to a diverse patient population requiring minimally invasive interventions.
Indications for Use
The FDA indications suggest that this guide wire is intended for use in procedures requiring the navigation of difficult anatomical pathways, such as those encountered in embolization or the treatment of ureteric strictures. It is designed to assist clinicians in accessing and treating areas that are otherwise challenging to reach.
Practical Considerations
The Merit Hydrophilic Guide Wire is available in various sizes to accommodate different anatomical requirements and procedural needs. It is compatible with a range of catheters and stents, and its hydrophilic coating requires activation with saline to reduce friction. Clinicians should be familiar with the wire's handling characteristics to optimize its use in procedures.
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.