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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 ?
510(k)
Number ?
K030549 ↗
Decision Date ?
May 14, 2003
Product Code ?
DQX Wire, Guide, Catheter
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.
FDA-Cleared Indications
- For use as a catheter guide wire during intravascular procedures.
- Intended to facilitate the placement and navigation of catheters within blood vessels.
Clinical Applications
- Guiding intravascular catheters through blood vessels during diagnostic or therapeutic procedures.
- Supporting catheter positioning when vascular access and navigation are required.
- Use with compatible catheter systems in procedures performed under fluoroscopic or other imaging guidance.
Practical Considerations
- The record includes Hi-Torque Pilot 50 and Hi-Torque Pilot 150 models; exact length, diameter, tip design, and catheter compatibility should be confirmed from the applicable product labeling.
- The hydrophilic coating is intended to reduce friction when wetted. Keep the wire hydrated according to the manufacturer's instructions and avoid handling the coating with dry gauze or other materials that may damage it.
- Use imaging guidance and compatible catheters; do not force the wire if resistance is encountered because vessel injury, dissection, perforation, or wire damage can occur.
- MRI safety depends on the specific model and labeling. Do not assume the guide wire is MR Safe or MR Conditional without confirming the manufacturer's current instructions for use.
- Contraindications, warnings, and precautions should be reviewed in the device labeling. The guide wire does not treat the underlying vascular condition by itself.
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-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.