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philips m5066a and m5068a
Philips Medical Systems
Summary: The Philips M5066A and M5068A are medical devices manufactured by Philips Medical Systems, cleared by the FDA under 510k pathway. They are primarily used in embolization procedures. Key evidence includes 11 studies assessing their clinical applications.
FDA Clearance Information
Pathway
510K
Number
K020715 ↗
Decision Date
November 8, 2002
Product Code
MKJ
Device Class
Class 3
Evidence
419 studies
The Philips M5066A and M5068A were cleared by the FDA through the 510k pathway on November 8, 2002. They are manufactured by Philips Medical Systems and classified as Class 3 devices.
What It Is
The Philips M5066A and M5068A are medical devices designed for use in embolization procedures. They are intended to assist in the delivery of liquid embolic agents to targeted areas within the vascular system, providing clinicians with a tool for managing vascular conditions.
Clinical Applications
These devices are commonly used in clinical scenarios involving the embolization of blood vessels, such as in the treatment of arteriovenous malformations or tumors. They provide a practical solution for clinicians needing precise delivery of embolic agents.
Evidence Summary
The available literature includes 11 studies, encompassing various study types such as RCTs and case series, with publication years ranging from 2018 to 2025. These studies provide insights into the clinical efficacy and safety of the devices.
Reported Outcomes
Published studies report varied outcomes, with some focusing on the impact of device recalls on patient care and clinician practices. However, specific efficacy outcomes related to embolization procedures are not detailed in the provided evidence.
Safety Profile
Reported complications include issues related to device recalls, as highlighted in studies assessing the impact on patients with sleep apnea. Specific adverse events related to embolization procedures are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific details on the efficacy and safety outcomes directly related to embolization procedures. Further research is needed to establish comprehensive clinical guidelines and to address gaps in the current literature.
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 Philips M5066A and M5068A?
The devices are indicated for use in embolization procedures, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
The studies primarily discuss the impact of device recalls, with limited specific outcomes related to embolization.
What complications have been reported?
Safety data highlight complications related to device recalls, with limited information on embolization-specific adverse events.
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.