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prelude snap splittable hydrophilic sheath introducer
Merit Medical Systems
Summary: The Prelude Snap Splittable Hydrophilic Sheath Introducer is a medical device used to facilitate vascular access during interventional procedures. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway 510K
Number K152381 ↗
Decision Date October 30, 2015
Product Code DYB
Device Class Class 2
Evidence 419 studies
The Prelude Snap Splittable Hydrophilic Sheath Introducer was cleared through the FDA 510(k) pathway on October 30, 2015. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Prelude Snap is a splittable hydrophilic sheath introducer designed to provide smooth vascular access. Its hydrophilic coating reduces friction, facilitating easier insertion into blood vessels. The splittable design allows for easy removal after catheter placement, minimizing trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as the deployment of embolization coils or liquid agents. It is suitable for use in both hospital and outpatient settings, often in patients requiring minimally invasive treatment for vascular conditions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the introduction of catheters into the vascular system. It is particularly useful in patients undergoing embolization procedures to treat aneurysms or other vascular abnormalities.
Practical Considerations
The Prelude Snap comes in various sizes to accommodate different vessel diameters and is compatible with a range of guidewires and catheters. Clinicians should ensure proper sizing and technique to minimize vascular trauma and optimize procedural 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 Prelude Snap Splittable Hydrophilic Sheath Introducer used for?
It is used to facilitate vascular access during interventional procedures, such as the introduction of catheters for embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for vascular access in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of catheters into the vascular system, particularly in embolization treatments.
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.