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Easy Pass Hydrophilic Coated Vascular Guidewire
Summary: The Easy Pass Hydrophilic Coated Vascular Guidewire is a medical device used to facilitate the placement of catheters and other devices within the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033542 ↗
Decision Date ?
December 5, 2003
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Easy Pass Hydrophilic Coated Vascular Guidewire was cleared through the FDA 510(k) pathway on December 5, 2003. It is manufactured by Galt Medical and classified as a Class 2 device under product code DQX.
What It Is
The Easy Pass Hydrophilic Coated Vascular Guidewire is a flexible wire with a hydrophilic coating that reduces friction, allowing it to navigate through blood vessels with ease. This guidewire is used to guide catheters and other devices to target locations within the vascular system. The hydrophilic coating enhances maneuverability and reduces the risk of vessel trauma.
FDA-Cleared Indications
- Facilitate the placement and navigation of catheters within the vascular system.
- Provide a guide for the introduction and positioning of compatible vascular devices during endovascular procedures.
- Support vascular procedures in which catheter navigation or delivery of a vascular device is required.
Clinical Applications
- Guiding catheters through blood vessels to a selected treatment location.
- Supporting endovascular procedures that require catheter or device positioning.
- Providing access during vascular interventions involving compatible devices.
- Helping navigate vascular anatomy when a flexible, hydrophilic guidewire is appropriate.
Practical Considerations
- The guidewire should be selected by diameter, length, tip configuration and compatibility with the intended catheter or device.
- Hydrophilic coatings become lubricious when wetted; the wire should be prepared and handled according to the manufacturer’s instructions.
- Use fluoroscopic or other appropriate imaging guidance and avoid forceful advancement, withdrawal or rotation if resistance is encountered.
- Potential complications include vessel injury, dissection, perforation, thrombosis, embolization, infection and guidewire fracture or separation.
- MRI safety depends on the specific product labeling and configuration. Confirm MR Safe, MR Conditional or MR Unsafe status before an MRI examination; do not assume that a generic guidewire category is MRI safe.
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 Easy Pass Hydrophilic Coated Vascular Guidewire used for?
It is used to facilitate the placement of catheters and other devices within the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The guidewire is indicated for use in navigating catheters through the vascular system, particularly in procedures involving liquid embolization agents.
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.