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Merit Hydrophilic Guide Wire
Summary: The Merit Hydrophilic Guide Wire is a medical device used for navigating through vascular and non-vascular pathways. It is primarily used by interventional radiologists and urologists to facilitate the placement of catheters and other devices.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170933 ↗
Decision Date ?
June 22, 2017
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Merit Hydrophilic Guide Wire was cleared through the FDA 510k pathway on June 22, 2017. It is manufactured by Merit Medical Systems and is 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 difficult anatomical pathways. Its hydrophilic coating reduces friction, allowing it to glide smoothly through vessels and other luminal structures. This makes it particularly useful in procedures where precision and ease of movement are critical.
FDA-Cleared Indications
- Used to facilitate the placement and positioning of catheters and other interventional devices.
- Intended for navigation through vascular and other luminal pathways during catheter-based procedures.
- Use is limited to the specific configurations, sizes, and anatomical applications described in the device labeling.
Clinical Applications
- Guide-wire support during vascular catheter placement.
- Navigation through tortuous or difficult vascular anatomy.
- Facilitation of access for catheter-based interventional procedures.
- Use with compatible catheters and other devices according to the product labeling.
Practical Considerations
- Available sizes and configurations vary; clinicians should select the wire diameter, length, tip design, and stiffness appropriate for the planned procedure.
- The hydrophilic coating requires preparation and maintenance according to the manufacturer’s instructions. Avoid allowing the wire to dry during use.
- Use only with compatible catheters and devices, and inspect the wire before use for coating damage, kinking, or other defects.
- MRI safety depends on the exact model and labeling. Confirm the current device-specific MR conditions before scanning.
- Potential complications include vessel or tissue injury, perforation, dissection, bleeding, thrombosis, infection, embolization, and wire damage or breakage.
Related Literature
The linked study explored the use of a hydrophilic coated guide wire in traversing tight ureteric strictures using a modified through and through technique. The study involved five cases where traditional methods failed, highlighting the guide wire's effectiveness in such challenging scenarios. However, the study's small sample size limits the generalizability of the findings.
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 difficult anatomical pathways, particularly in vascular and urinary tract procedures, to facilitate the placement of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and urologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the navigation of tight or tortuous pathways, such as those in vascular or urinary tract interventions.
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.