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cath seal
Universal Medical Instrument
Summary: Cath Seal is a vascular closure device used primarily in cardiac catheterization procedures. It is FDA 510k cleared and linked to 13 studies, focusing on outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K962180 ↗
Decision Date
November 7, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
Cath Seal was cleared by the FDA via the 510k pathway on November 7, 1996. It is manufactured by Universal Medical Instrument and classified as a Class 2 device.
What It Is
Cath Seal is a vascular closure device designed to achieve hemostasis following catheterization procedures. It is used to seal the femoral artery puncture site, reducing manual compression time.
Clinical Applications
Cath Seal is commonly used in cardiac catheterization and percutaneous coronary intervention (PCI) to facilitate rapid hemostasis and reduce time to ambulation. It is particularly useful in patients undergoing femoral artery access.
Evidence Summary
The available literature includes 13 studies, with a range of study types such as RCTs and retrospective analyses. The studies span from 2011 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report variable rates of vascular complications with Cath Seal compared to manual compression. Some studies highlight its effectiveness in reducing hemostasis time and improving patient comfort post-procedure.
Safety Profile
Reported complications include vascular complications such as hematoma and pseudoaneurysm formation. The safety profile is comparable to other closure devices, with some studies noting a lower incidence of complications compared to manual compression.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and patient populations. Further research is needed to assess long-term outcomes and compare efficacy across different patient demographics.
Frequently Asked Questions
What are the clinical indications for Cath Seal?
Cath Seal is indicated for use in achieving hemostasis following femoral artery catheterization procedures, such as cardiac catheterization and PCI.
What outcomes have been reported in clinical studies?
Studies report reduced hemostasis time and improved patient comfort, with variable rates of vascular complications compared to manual compression.
What complications have been reported?
Safety data indicate complications such as hematoma and pseudoaneurysm formation, with a safety profile comparable to other closure devices.
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.