đź“‹ FDA Reference

merit hydrophilic guide wire

Merit Medical Systems

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 510K
Decision Date July 29, 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 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.

Clinical Applications

This guide wire is commonly used in interventional radiology and urology for procedures such as angiography, embolization, and the treatment of ureteric strictures. It is particularly beneficial in cases where traditional guide wires may struggle to pass through tight or tortuous areas. The device is used in both hospital and outpatient settings, often in patients requiring vascular or urinary interventions.

Indications for Use

The FDA-cleared indications for the Merit Hydrophilic Guide Wire include its use in facilitating the placement of devices during vascular and non-vascular procedures. It is particularly indicated for patients with conditions that involve narrowed or obstructed pathways, such as strictures.

Practical Considerations

The Merit Hydrophilic Guide Wire is available in various lengths and diameters to suit different procedural needs. It is compatible with a range of catheters and devices, making it versatile for multiple applications. Clinicians should be aware of the potential for the wire to become slippery when wet, requiring careful handling.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.