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exoseal r vascular closure device
Cordis Us
Summary: The Exoseal R Vascular Closure Device is used to close vascular access sites post-catheterization. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
PMA
Number
P100013 ↗
Decision Date
January 8, 2026
Product Code
MGB
Device Class
Class 3
Evidence
0 studies
The Exoseal R Vascular Closure Device received FDA clearance via PMA P100013 on January 8, 2026. Manufactured by Cordis Us, it is classified as a Class 3 medical device.
What It Is
The Exoseal R Vascular Closure Device is designed to seal femoral artery punctures following catheter-based procedures. It works by deploying a bioabsorbable plug at the access site, promoting hemostasis. This device helps reduce time to ambulation and discharge, enhancing patient comfort and procedural efficiency.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is employed after procedures like angiography or angioplasty. It is suitable for use in hospital settings, particularly in catheterization labs, and is beneficial for patients undergoing diagnostic or therapeutic vascular interventions.
Indications for Use
The FDA indications allow for the modification of receiving inspection levels for specific part numbers, ensuring quality control. Clinically, it is indicated for patients requiring femoral artery closure post-catheterization.
Practical Considerations
The Exoseal R is available in various sizes to accommodate different femoral artery diameters. It is compatible with standard catheterization equipment and requires specific deployment techniques to ensure effective closure.
Frequently Asked Questions
What is Exoseal R Vascular Closure Device used for?
It is used to close femoral artery access sites after catheterization procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for closing femoral artery punctures post-catheterization, with updated inspection levels for quality control.
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.