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Exoseal R Vascular Closure Device
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, Hemostasis, Vascular
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.
FDA-Cleared Indications
- Approval to change the receiving inspection level for 15 specified part numbers.
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.
Practical Considerations
- The supplied FDA indication is a manufacturing and quality-control change, not a new clinical indication for vascular closure.
- The device record does not provide approved vessel-size ranges, device sizes, MRI labeling, contraindications, or compatibility requirements.
- Clinical use should follow the current manufacturer instructions for use, including access-site selection, deployment technique, and patient-selection criteria.
- Do not infer MRI safety, use in nonfemoral vessels, or compatibility with specific sheaths or catheters without confirming the current product labeling.
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.