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Hi-Toque Whisper Ls and Ms Guide Wire with Hydrocoat Hydrophilic Coating
Guidant
Summary: The hi-toque whisper ls and ms guide wire with hydrocoat hydrophilic coating is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists, to navigate through blood vessels. It is designed to aid in the placement of catheters and other devices.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013092 ↗
Decision Date ?
December 13, 2001
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The hi-toque whisper ls and ms guide wire was cleared through the FDA 510(k) pathway on December 13, 2001. It is manufactured by Guidant and classified as a Class 2 medical device.
What It Is
The hi-toque whisper ls and ms guide wire is a specialized guide wire featuring a hydrophilic coating known as Hydrocoat, which enhances its ability to glide smoothly through blood vessels. This device is used to facilitate the placement of catheters and other interventional tools within the vascular system. Its design allows for improved maneuverability and reduced friction, making it particularly useful in complex vascular procedures.
FDA-Cleared Indications
- Used to facilitate the placement and positioning of catheters and other intravascular devices during vascular procedures.
- Intended for use in the peripheral and coronary vasculature, according to the applicable device labeling.
- Used as an adjunct during endovascular procedures in which vascular access and device navigation are required.
Clinical Applications
- Guiding catheters or other intravascular devices through blood vessels during endovascular treatment.
- Facilitating device placement during catheter-based vascular procedures.
- Supporting navigation through vessels that are narrow, curved or difficult to access, when consistent with the device labeling.
Practical Considerations
- The LS and MS versions may be available in different wire lengths, diameters and tip configurations; the selected size must match the catheter, access site and target anatomy.
- Hydrophilic coatings require appropriate preparation and continuous wetting according to the instructions for use. A dry or damaged coating can increase friction and may contribute to vessel or device injury.
- The wire must be compatible with the inner diameter and configuration of the catheter or other device used.
- The FDA record identifies this as a guide wire for vascular procedures; MRI safety should be confirmed from the current product labeling before scanning.
- Use requires trained personnel and careful fluoroscopic or other appropriate imaging guidance. Vascular injury, dissection, perforation, thrombosis and embolization are potential procedural risks.
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 whisper ls and ms guide wire used for?
It is used to navigate through blood vessels and facilitate the placement of catheters and other interventional devices during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures such as angioplasty and embolization.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of devices during vascular procedures, such as those treating embolization and other vascular conditions.
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.