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europhilic slippery coated foley catheter
Baxter Healthcare
Summary: The europhilic slippery coated foley catheter is a medical device used for urinary drainage. It's primarily utilized by urologists and healthcare professionals in hospital settings for patients requiring catheterization.
FDA Clearance Information
Pathway
510K
Number
K944007 ↗
Decision Date
June 29, 1995
Product Code
EZL
Device Class
Class 2
Evidence
419 studies
This device was cleared through the FDA 510(k) pathway on June 29, 1995. Manufactured by Baxter Healthcare, it is classified as a Class 2 device under product code EZL.
What It Is
The europhilic slippery coated foley catheter is a urinary catheter designed with a hydrophilic coating to reduce friction during insertion and removal. This coating enhances patient comfort and minimizes the risk of urethral trauma. The catheter is typically made of flexible material and is used to drain urine from the bladder in patients who cannot do so naturally.
Clinical Applications
Commonly used in urology, the catheter is employed in both acute and chronic urinary retention scenarios. It is also used in surgical settings for perioperative bladder management and in patients with neurogenic bladder disorders. The device is suitable for use in hospitals, long-term care facilities, and home care settings.
Indications for Use
The FDA indications suggest this catheter is intended for patients needing urinary drainage due to conditions like urinary retention or post-surgical management. It is suitable for both short-term and long-term catheterization.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard urinary drainage systems. Proper insertion technique is crucial to minimize infection risk and ensure patient comfort.
Related Literature
The linked study explores the development of multifunctional 'hydrogel skins' on polymers, enhancing surface properties like slipperiness and hydrophilicity. While not specific to this catheter, the study's findings support the benefits of hydrophilic coatings in medical devices. Limitations include the focus on material science rather than direct clinical outcomes.
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 europhilic slippery coated foley catheter used for?
It is used for urinary drainage in patients who cannot urinate naturally, such as those with urinary retention or post-surgery.
What specialties typically use this device?
Urology, surgery, and long-term care specialties commonly use this catheter.
What are the FDA-cleared indications?
The catheter is indicated for urinary drainage in patients with conditions like urinary retention or requiring post-surgical bladder management.
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.