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pvc hydrophilic urethral catheter
Chengdu Daxan Innovative Medical Tech.
Summary: The PVC hydrophilic urethral catheter is designed for urinary drainage with a hydrophilic coating to reduce friction. Key evidence highlights its potential to reduce urinary tract infections compared to non-hydrophilic catheters.
FDA Clearance Information
Pathway
510K
Number
K212567 ↗
Decision Date
December 7, 2022
Product Code
EZD
Device Class
Class 2
Evidence
419 studies
The PVC hydrophilic urethral catheter by Chengdu Daxan Innovative Medical Tech. was cleared via the FDA 510(k) pathway on December 7, 2022. It is classified as a Class 2 device under product code EZD.
What It Is
The PVC hydrophilic urethral catheter is a medical device used for urinary drainage. It features a hydrophilic coating that activates upon contact with water, reducing friction during insertion and removal, thus minimizing urethral trauma.
Clinical Applications
This catheter is commonly used in clean intermittent catheterization (CIC) for patients with bladder dysfunctions. It is particularly useful in reducing complications associated with traditional catheters, such as urinary tract infections and urethral trauma.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials, meta-analyses, and systematic reviews, published between 2017 and 2025. These studies evaluate the efficacy and safety of hydrophilic versus non-hydrophilic catheters.
Reported Outcomes
Published studies report that hydrophilic catheters are associated with a reduced incidence of urinary tract infections and urethral trauma compared to non-hydrophilic catheters. The hydrophilic coating is noted to improve patient comfort and ease of use during catheterization.
Safety Profile
Reported complications include urinary tract infections, urethral trauma, and hematuria. However, the hydrophilic coating is suggested to mitigate these risks compared to conventional PVC catheters.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term outcome data. Further research is needed to establish the long-term safety and efficacy of hydrophilic catheters in diverse patient populations.
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 are the clinical indications for PVC hydrophilic urethral catheter?
The catheter is indicated for clean intermittent catheterization in patients with bladder dysfunctions to reduce urinary tract infections and urethral trauma.
What outcomes have been reported in clinical studies?
Studies report reduced urinary tract infections and improved patient comfort with hydrophilic catheters compared to non-hydrophilic ones.
What complications have been reported?
Safety data indicate complications such as urinary tract infections and urethral trauma, though these are less frequent with hydrophilic coatings.
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.