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Lake Region Hydrophilic Guidewire
Lake Region Mfg.
Summary: The Lake Region Hydrophilic Guidewire is a medical device used primarily in endovascular procedures to navigate through blood vessels. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K040825 ↗
Decision Date ?
May 17, 2004
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Lake Region Hydrophilic Guidewire was cleared through the FDA 510(k) pathway on May 17, 2004. It is manufactured by Lake Region Mfg. and is classified as a Class 2 device.
What It Is
The Lake Region Hydrophilic Guidewire is a flexible, coated wire designed to facilitate the navigation of catheters through the vascular system. Its hydrophilic coating reduces friction, allowing for smoother passage through blood vessels. This guidewire is particularly useful in complex vascular procedures where precise maneuverability is required.
FDA-Cleared Indications
- For use in conjunction with compatible catheters during endovascular procedures.
- For guiding and positioning catheters within the vascular system.
- For procedures involving the delivery of liquid embolization agents, as described in the FDA-cleared labeling.
Clinical Applications
- Catheter navigation during vascular diagnostic procedures.
- Catheter positioning for endovascular treatment procedures.
- Vascular access and catheter delivery when liquid embolization agents are used.
- Navigation through selected tortuous or small blood vessels when compatible with the labeled catheter system.
Practical Considerations
- Available guidewire diameter and length should be matched to the catheter, access route, target vessel, and procedure.
- Use only with compatible catheters and accessories according to the device labeling.
- Hydrophilic guidewires generally require appropriate wetting or preparation before use; follow the manufacturer’s instructions.
- Advance and withdraw the wire under fluoroscopic guidance using gentle technique to reduce the risk of vessel dissection, perforation, or other injury.
- MRI safety and conditional-use information must be confirmed in the current manufacturer’s labeling; do not assume that a guidewire is MRI safe.
Related Literature
The linked study explored the use of radial artery access for cerebral angiography, highlighting its safety compared to femoral access. Key findings included a reduction in access site complications and improved patient preference for the radial approach. However, the study's limitations include its focus on a single access site and the need for further research to generalize findings.
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 Lake Region Hydrophilic Guidewire used for?
It is used to navigate catheters through blood vessels in endovascular procedures.
What specialties typically use this device?
Interventional radiologists, cardiologists, and neurointerventionalists commonly use this device.
What are the FDA-cleared indications?
The guidewire is indicated for use in procedures involving liquid embolization agents, primarily for vascular access in diagnostic or therapeutic interventions.
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.