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ultraskin hydrophilic guide wire

Lepu Medical Technology (Beijing)

Summary: The Ultraskin Hydrophilic Guide Wire is a medical device used to facilitate the navigation of catheters through blood vessels. It is commonly used by interventional radiologists and cardiologists during procedures such as embolization.

FDA Clearance Information

Pathway 510K
Decision Date January 21, 2015
Product Code DQX
Device Class Class 2
Evidence 419 studies

The Ultraskin Hydrophilic Guide Wire, manufactured by Lepu Medical Technology (Beijing), was cleared through the FDA 510(k) pathway on January 21, 2015. It is classified as a Class 2 device under product code DQX.

What It Is

The Ultraskin Hydrophilic Guide Wire is a specialized wire with a hydrophilic coating that enhances its ability to navigate through the vascular system. This coating reduces friction, allowing for smoother passage through blood vessels, which is critical during minimally invasive procedures. The guide wire's design helps clinicians reach target areas with precision, facilitating the delivery of therapeutic devices.

Clinical Applications

This guide wire is primarily used in interventional radiology and cardiology for procedures that require the placement of catheters in difficult-to-reach areas of the vascular system. Common scenarios include embolization procedures, where precise navigation is crucial to deliver embolic agents to specific sites. It is also used in angioplasty and other interventions that require access to narrow or tortuous vessels.

Indications for Use

The FDA-cleared indications for the Ultraskin Hydrophilic Guide Wire involve its use in procedures requiring the navigation of catheters through blood vessels. It is suitable for patients needing interventions like embolization, where precise catheter placement is essential.

Practical Considerations

The Ultraskin Hydrophilic Guide Wire is available in various sizes to accommodate different vascular anatomies. Its hydrophilic coating requires activation with saline or other fluids before use. Clinicians should ensure compatibility with the catheters and devices being used in the procedure.

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

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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

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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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 Ultraskin Hydrophilic Guide Wire used for?

It is used to facilitate the navigation of catheters through blood vessels during procedures such as embolization and angioplasty.

What specialties typically use this device?

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

What are the FDA-cleared indications?

The device is indicated for use in navigating catheters through blood vessels, particularly in procedures like embolization where precise placement is necessary.

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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