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Vasostasis Vascular Closure System
Summary: The Vasostasis Vascular Closure System is a medical device used to achieve hemostasis after vascular procedures. It is primarily used by interventional cardiologists and radiologists to close femoral artery access sites.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K041486 ↗
Decision Date ?
October 22, 2004
Product Code ?
DXC Clamp, Vascular
Device Class ?
Class 2
Evidence ?
0 studies
The Vasostasis Vascular Closure System was cleared through the FDA 510(k) pathway on October 22, 2004. Manufactured by Cardiva Medical, it is classified as a Class 2 device under product code DXC.
What It Is
The Vasostasis Vascular Closure System is designed to facilitate hemostasis following catheterization procedures. It works by applying mechanical pressure to the femoral artery access site, promoting clot formation and reducing bleeding. This device is particularly useful in reducing time to hemostasis and patient recovery time compared to manual compression.
FDA-Cleared Indications
- Use after catheter-based vascular procedures that require closure of a femoral artery access site.
- Aid hemostasis at the femoral artery puncture site following catheterization procedures.
Clinical Applications
- Femoral artery access-site closure after diagnostic angiography.
- Femoral artery hemostasis after interventional cardiology catheterization procedures.
- Femoral artery hemostasis after interventional radiology catheter-based procedures.
- Closure of femoral artery access sites following percutaneous vascular procedures.
Practical Considerations
- The device is intended for femoral artery access-site management; the available FDA record does not establish use for venous, radial, brachial, or other access sites.
- Use requires appropriate assessment of the puncture site and vascular anatomy before deployment.
- Clinicians should follow the device-specific instructions for use, including access-site preparation, positioning, compression, and monitoring.
- The FDA record identifies the device as a Class II vascular clamp under product code DXC; it does not provide enough information here to confirm specific sheath or vessel-size compatibility.
- MRI safety information is not provided in the supplied FDA record. Check the current labeling before an MRI examination.
Frequently Asked Questions
What is Vasostasis Vascular Closure System used for?
It is used to achieve hemostasis after vascular procedures involving femoral artery access.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for closure of femoral artery access sites following vascular procedures.
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.