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cath-seal
Universal Medical Instrument
Summary: Cath-seal is a vascular closure device used primarily in embolization procedures. It is FDA 510k cleared and linked to studies assessing its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K822247 ↗
Decision Date
August 19, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
Cath-seal was cleared through the FDA 510k pathway on August 19, 1982, by Universal Medical Instrument. It is classified as a Class 2 device under product code DYB.
What It Is
Cath-seal is a vascular closure device designed to achieve hemostasis following catheterization procedures. It is used in clinical settings to prevent bleeding and promote vessel closure after interventions such as embolization.
Clinical Applications
Cath-seal is commonly used in procedures requiring vascular access, such as embolization-coils, to ensure rapid and effective closure of the vessel. It is particularly useful in interventional radiology and cardiology settings.
Evidence Summary
The available literature includes five studies, primarily clinical trials, assessing the efficacy and safety of cath-seal. These studies span various clinical applications and provide insights into the device's performance.
Reported Outcomes
Published studies report that cath-seal effectively achieves hemostasis in vascular procedures. The device has been compared to other closure methods, showing comparable or improved outcomes in terms of closure time and patient recovery.
Safety Profile
Reported complications include minor bleeding and hematoma formation, which are consistent with other vascular closure devices. No major adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of recent data. Further research is needed to confirm long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for cath-seal?
Cath-seal is indicated for use in achieving hemostasis following catheterization procedures, particularly in embolization-coils.
What outcomes have been reported in clinical studies?
Studies report effective hemostasis with cath-seal, with outcomes comparable to or better than other closure methods.
What complications have been reported?
Safety data indicate minor complications such as bleeding and hematoma, with no major adverse events reported.
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.