đź“‹ FDA Reference
Hi-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating 1009659 1009659j 1009660 10096
Guidant
Summary: The Hi-Toque Balance Middleweight Universal Guide Wire by Guidant is a medical device used in vascular procedures to navigate through blood vessels. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013833 ↗
Decision Date ?
January 16, 2002
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Hi-Toque Balance Guide Wire was cleared through the FDA 510(k) pathway on January 16, 2002. Manufactured by Guidant, it is classified as a Class 2 medical device.
What It Is
The Hi-Toque Balance Middleweight Universal Guide Wire is a flexible wire with a hydrophilic coating designed to facilitate the navigation of catheters through the vascular system. Its hydrocoat hydrophilic coating reduces friction, allowing for smoother passage through blood vessels. This device is crucial in procedures requiring precise catheter placement.
FDA-Cleared Indications
- For use in conjunction with compatible catheters during vascular procedures.
- Intended to facilitate the placement and navigation of catheters within the vascular system.
- Labeled for use in procedures involving liquid embolization agents, when used with compatible catheter systems.
Clinical Applications
- Catheter navigation during vascular access and interventional procedures.
- Guiding compatible catheters through vessels to the intended treatment location.
- Use with liquid embolization agent delivery systems when specified by the applicable catheter and embolization-device labeling.
Practical Considerations
- The record includes multiple model or catalog identifiers, including 1009659, 1009659J, 1009660 and 10096; the exact wire diameter, working length and tip configuration should be confirmed from the device labeling.
- The hydrophilic coating is intended to reduce friction when the wire is wet. Follow the manufacturer's instructions for preparation, flushing and handling.
- Use only with compatible catheters and accessories, and do not force the wire against resistance because this can cause vessel or device injury.
- This is a single-use device and should not be resterilized or reused.
- MRI safety status is not established by the supplied FDA record. Check the current manufacturer labeling before MRI exposure; do not assume the device is MR safe or MR conditional.
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 Hi-Toque Balance Guide Wire used for?
It is used to navigate catheters through blood vessels during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures involving liquid embolization agents, particularly in vascular 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.