đź“Š Evidence-Based Reference
spectrum central venous catheter with or without hydrophilic coating
Cook
Summary: The spectrum central venous catheter by Cook is used for central venous access in various clinical settings. Key evidence highlights its role in reducing infection risks with hydrophilic coating.
FDA Clearance Information
Pathway
510K
Number
K033843 ↗
Decision Date
August 12, 2004
Product Code
FOZ
Device Class
Class 2
Evidence
419 studies
The spectrum central venous catheter was cleared by the FDA via the 510(k) pathway on August 12, 2004. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The spectrum central venous catheter is a medical device designed for central venous access, facilitating the administration of medications, fluids, and parenteral nutrition. It may feature a hydrophilic coating to reduce infection risks.
Clinical Applications
This catheter is commonly used in intensive care units, oncology, and long-term intravenous therapy settings. It is particularly useful for patients requiring frequent venous access.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, spanning from 2022 to 2025. These studies focus on infection risks and catheter-related complications.
Reported Outcomes
Published studies report that the use of hydrophilic-coated catheters is associated with a reduction in central line-associated bloodstream infections (CLABSIs). The evidence suggests improved patient outcomes and reduced healthcare costs.
Safety Profile
Reported complications include catheter-associated bloodstream infections and invasive fungal infections, such as candidiasis and Malassezia infections. These complications are more prevalent in immunocompromised patients.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish standardized protocols and long-term outcomes of catheter use.
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 spectrum central venous catheter?
The catheter is indicated for central venous access in patients requiring long-term intravenous therapy, including medication administration and parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies report a reduction in infection rates, particularly CLABSIs, with the use of hydrophilic-coated catheters.
What complications have been reported?
Safety data indicate risks of bloodstream infections and invasive fungal infections, especially in immunocompromised patients.
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.