đź“‹ FDA Reference

hi-torque pilot 50 guide wire with hydrocoat hydrophilic coating hi-torque pilot 150 guide wire with hydrocoat hydrophg

Guid

Summary: The Hi-Torque Pilot Guide Wire is a medical device used in interventional procedures to navigate through blood vessels. It is typically used by cardiologists and interventional radiologists for procedures involving embolization.

FDA Clearance Information

Pathway 510K
Decision Date May 14, 2003
Product Code DQX
Device Class Class 2
Evidence 419 studies

The Hi-Torque Pilot Guide Wire was cleared through the FDA 510(k) pathway on May 14, 2003. Manufactured by Guid, this device is classified as Class 2 under product code DQX.

What It Is

The Hi-Torque Pilot Guide Wire is a specialized medical device designed for navigating through vascular systems. It features a hydrophilic coating that enhances maneuverability and reduces friction, making it easier to guide through complex vascular pathways. This guide wire is crucial in procedures where precise navigation is required, such as in angioplasty or embolization.

Clinical Applications

The Hi-Torque Pilot Guide Wire is commonly used in interventional cardiology and radiology. It is particularly useful in procedures that require the placement of stents or embolization agents in the treatment of vascular diseases. This device is suitable for use in hospital settings, particularly in catheterization labs, and is used in adult and pediatric populations with vascular conditions.

Indications for Use

The FDA indications for this device include its use in procedures requiring the navigation of blood vessels, such as embolization. It is intended for patients who need precise vascular access and treatment, often due to blockages or aneurysms.

Practical Considerations

The Hi-Torque Pilot Guide Wire comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with the hydrophilic coating, which requires specific handling techniques to maintain its effectiveness.

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 Hi-Torque Pilot Guide Wire used for?

It is used for navigating through blood vessels during interventional procedures like angioplasty and embolization.

What specialties typically use this device?

Interventional cardiologists and radiologists commonly use this device.

What are the FDA-cleared indications?

The device is indicated for use in procedures requiring vascular navigation, such as embolization.

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.

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