đź“‹ FDA Reference

hi-torque balance iniversal guide wire with hydrocoat hydrophilic coating

Guidant

Summary: The Hi-Torque Balance Universal Guide Wire with Hydrocoat hydrophilic coating is a medical device used in interventional procedures to facilitate the placement of catheters. It is primarily used by interventional cardiologists and radiologists.

FDA Clearance Information

Pathway 510K
Decision Date August 26, 2003
Product Code DQX
Device Class Class 2
Evidence 419 studies

The Hi-Torque Balance Universal Guide Wire was cleared through the FDA 510(k) pathway on August 26, 2003. Manufactured by Guidant, it is classified as a Class 2 device under product code DQX.

What It Is

The Hi-Torque Balance Universal Guide Wire is a specialized guide wire featuring a hydrophilic coating known as Hydrocoat, which enhances its maneuverability through blood vessels. This device is designed to assist in the navigation and placement of catheters during interventional procedures, providing support and stability. The hydrophilic coating reduces friction, allowing for smoother passage through tortuous anatomy.

Clinical Applications

This guide wire is commonly used in interventional cardiology and radiology for procedures such as angioplasty and embolization. It is particularly useful in navigating complex vascular pathways and is employed in both coronary and peripheral interventions. The device is suitable for use in hospitals and specialized clinics, catering to patients requiring minimally invasive vascular procedures.

Indications for Use

The FDA indications for this device include its use in facilitating the placement of catheters during procedures that involve liquid embolization agents. It is intended for patients requiring vascular interventions where precise catheter placement is critical.

Practical Considerations

The Hi-Torque Balance Universal Guide Wire typically comes in various lengths and diameters to accommodate different procedural needs. It is compatible with a range of catheters and should be selected based on the specific vascular anatomy and procedural requirements. Proper technique is essential to maximize the benefits of the hydrophilic coating.

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 Balance Universal Guide Wire used for?

It is used to facilitate the placement of catheters during interventional procedures, particularly in vascular interventions.

What specialties typically use this device?

Interventional cardiologists and radiologists commonly use this device in their procedures.

What are the FDA-cleared indications?

The device is indicated for use in procedures involving liquid embolization agents, assisting in catheter placement.

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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