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Hi-Torque Whisper Ls Guide Wire with Hydrocoat Hydrophilic Coating Hi-Torque Whisper Ms Guide Wire with Hydrocoat Hydro
Guidant
Summary: The Hi-Torque Whisper Guide Wire is a medical device used in vascular procedures to navigate through blood vessels. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002206 ↗
Decision Date ?
August 24, 2000
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Hi-Torque Whisper Guide Wire was cleared through the FDA 510(k) pathway on August 24, 2000. Manufactured by Guidant, it is classified as a Class 2 device.
What It Is
The Hi-Torque Whisper Guide Wire is a specialized guide wire with a hydrophilic coating, designed to facilitate the navigation of catheters through the vascular system. The hydrophilic coating reduces friction, allowing for smoother passage through blood vessels. It is particularly useful in complex vascular procedures where precision and control are critical.
FDA-Cleared Indications
- Used to guide and position catheters within the vascular system during diagnostic or interventional procedures.
- Intended for use in blood vessels where catheter navigation and placement are required.
- The device is a Class II catheter guide wire cleared through the FDA 510(k) pathway under product code DQX.
Clinical Applications
- Guiding catheters through blood vessels during vascular diagnostic procedures.
- Helping position catheters during angioplasty and other endovascular interventions when consistent with the specific device labeling.
- Supporting catheter navigation in coronary or peripheral vascular procedures when the selected wire size and configuration are appropriate.
- Facilitating catheter placement under fluoroscopic guidance.
Practical Considerations
- The device is available in different lengths and diameters; selection depends on the access site, target vessel, catheter compatibility and procedural anatomy.
- The Hydrocoat hydrophilic coating becomes lubricious when wetted. Keep the wire hydrated according to the instructions for use and handle it carefully to avoid coating damage.
- Use with compatible guide catheters, diagnostic catheters or interventional catheters, and confirm compatibility before use.
- Advance and withdraw the wire under fluoroscopic guidance. Resistance should be evaluated rather than overcome with force because vessel injury, dissection or wire damage can occur.
- MRI safety depends on the exact model and labeling. Do not assume that this device is MR Safe or MR Conditional without checking the current manufacturer instructions for use.
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 Whisper Guide Wire used for?
It is used to navigate catheters through blood vessels during vascular procedures, such as angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in navigating catheters through blood vessels during vascular procedures.
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.