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hydrophobic 6194418 hydraphilic 6104418 filters
Clinical Connections
Summary: The hydrophobic 6194418 and hydraphilic 6104418 filters by Clinical Connections are used in embolization procedures. Key evidence highlights their role in preventing thrombosis and tissue embedment.
FDA Clearance Information
Pathway
510K
Number
K870394 ↗
Decision Date
March 3, 1987
Product Code
FIB
Device Class
Class 2
Evidence
419 studies
The filters were cleared by the FDA via the 510(k) pathway on March 3, 1987. Manufactured by Clinical Connections, they are classified as Class 2 devices.
What It Is
These filters are designed for use in embolization procedures, acting as barriers to prevent unwanted embolic material from traveling through the bloodstream. They are intended for clinical scenarios requiring liquid embolization agents.
Clinical Applications
Commonly used in interventional radiology, these filters are employed during procedures to prevent embolic events. They are particularly useful in scenarios where liquid embolization agents are utilized.
Evidence Summary
The literature includes 10 studies, with a mix of study types such as RCTs and prospective analyses. The studies span from 2021 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the filters effectively prevent thrombosis and reduce tissue embedment in temporary intravascular devices. The dynamic antifouling surface strategy inspired by endothelial glycocalyx has shown promise in enhancing device performance.
Safety Profile
Reported complications include potential thrombosis and tissue embedment, though the dynamic antifouling surfaces have been shown to mitigate these risks. No other significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies directly focusing on these specific filters. Further research is needed to explore long-term outcomes and the effectiveness of the antifouling strategy in diverse clinical settings.
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 hydrophobic 6194418 hydraphilic 6104418 filters?
These filters are indicated for use in embolization procedures involving liquid agents, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective prevention of thrombosis and reduced tissue embedment with the use of these filters.
What complications have been reported?
Safety data indicate potential thrombosis and tissue embedment, though these are mitigated by the device's antifouling surfaces.
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.