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prelude wave hydrophilic sheath introducer
Merit Medical Systems
Summary: The Prelude Wave Hydrophilic Sheath Introducer is a medical device used to facilitate vascular access during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway 510K
Number K250909 ↗
Decision Date April 25, 2025
Product Code DYB
Device Class Class 2
Evidence 419 studies
The Prelude Wave Hydrophilic Sheath Introducer was cleared through the FDA 510(k) pathway on April 25, 2025. It is manufactured by Merit Medical Systems and is classified as a Class 2 device under product code DYB.
What It Is
The Prelude Wave Hydrophilic Sheath Introducer is a device designed to provide smooth and efficient vascular access. It features a hydrophilic coating that reduces friction during insertion, minimizing trauma to the vessel. This device is typically used in procedures requiring the introduction of catheters or other instruments into the vascular system.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Prelude Wave is employed during procedures such as angiography, embolization, and catheter-based interventions. It is suitable for use in both hospital and outpatient settings, and is often used in adult patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters and other devices into the vascular system. It is used in patients requiring vascular access for procedures involving embolization coils or liquid agents.
Practical Considerations
The Prelude Wave is available in various sizes to accommodate different vessel diameters and procedural needs. Its hydrophilic coating requires activation with saline before use. Clinicians should ensure compatibility with other devices used in the procedure.
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 Prelude Wave Hydrophilic Sheath Introducer used for?
It is used to facilitate vascular access during interventional procedures, allowing for the introduction of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system, particularly in procedures involving embolization coils or liquid 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.