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Splashwire Hydrophilic Guide Wire Mswstd35180j1o5 Splashwire Hydrophilic Guide Wire Mswstd35260j1o5 Splashwire Hydrophilic Guide Wire Mswstda35150lt Splashwire Hydrophilic Guide Wire Mswstfa35260lt Splashwire Hydrophilic Guide Wire Mswstfa35150lt Splashwire Hydrophilic Guide Wire Mswstfs38150lt
Merit Medical Ireland
Summary: The Splashwire Hydrophilic Guide Wire is a medical device used primarily for vascular access and catheter placement. Key evidence highlights its role in reducing air embolism during central venous catheter exchanges.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K251181 ↗
Decision Date ?
August 29, 2025
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The Splashwire Hydrophilic Guide Wire is cleared via the FDA 510(k) pathway on 2025-08-29. It is manufactured by Merit Medical Ireland and classified as a Class 2 device.
What It Is
The Splashwire Hydrophilic Guide Wire is designed to facilitate the placement of catheters within the vascular system. Its hydrophilic coating allows for smooth navigation through blood vessels, minimizing trauma to vessel walls.
FDA-Cleared Indications
- Used to facilitate the placement of catheters within the vascular system.
- Used as a guide wire during vascular access and catheter placement procedures.
- Intended for use with compatible catheters and interventional devices according to their labeling.
Clinical Applications
- Guiding catheter placement during percutaneous vascular access
- Supporting catheter exchange procedures
- Facilitating navigation through the vascular system during interventional procedures
- Providing a wire platform for placement of compatible vascular catheters
Evidence Summary
The literature includes 10 studies ranging from 2020 to 2024, encompassing various study types such as RCTs and case series. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Splashwire Hydrophilic Guide Wire effectively reduces air embolism risk during central venous catheter exchanges. It is also noted for its utility in challenging vascular access scenarios.
Safety Profile
Reported complications include rare instances of the hydrophilic coating detaching and migrating within the vascular system. Such events underline the importance of careful handling and monitoring during use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Practical Considerations
- Available configurations include approximately 0.035- and 0.038-inch wire diameters, with listed lengths ranging from about 150 to 260 cm.
- Confirm that the wire diameter, length, tip design, and stiffness are compatible with the catheter and planned access route.
- Hydrophilic coatings require wetting with sterile fluid according to the manufacturer’s instructions; the wire should not be advanced or withdrawn through a dry catheter.
- Use continuous imaging and gentle manipulation. Do not force the wire if resistance or unusual vessel anatomy is encountered.
- MRI compatibility depends on the specific labeling and configuration. Verify the current manufacturer’s MRI conditions before scanning; this device is not automatically assumed to be MRI safe.
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 Splashwire Hydrophilic Guide Wire?
The device is indicated for use in vascular access procedures, particularly where smooth catheter placement is required.
What outcomes have been reported in clinical studies?
Studies have reported effective reduction in air embolism risk and successful navigation in complex vascular procedures.
What complications have been reported?
Safety data indicate rare occurrences of hydrophilic coating detachment, emphasizing the need for careful device handling.
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.