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safecross vascular introducer system 4001
East End Medical I
Summary: The Safecross Vascular Introducer System 4001 is a medical device used to facilitate vascular access during procedures such as embolization. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K240600 ↗
Decision Date
September 6, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Safecross Vascular Introducer System 4001, manufactured by East End Medical, received FDA clearance through the 510k pathway on September 6, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The Safecross Vascular Introducer System 4001 is designed to aid in the introduction of catheters and other devices into the vascular system. It typically consists of a sheath and dilator, allowing for smooth and controlled access to blood vessels. This system is crucial in procedures requiring precise vascular entry, minimizing trauma and improving procedural outcomes.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving embolization, where precise vascular access is critical. It is suitable for use in hospitals and specialized clinics, catering to adult and pediatric patients requiring vascular interventions. Clinicians rely on it for its reliability and ease of use in complex vascular procedures.
Indications for Use
The FDA-cleared indications for the Safecross Vascular Introducer System 4001 include facilitating vascular access during procedures like embolization. It is intended for patients undergoing interventions that require catheter-based access to blood vessels.
Practical Considerations
The Safecross Vascular Introducer System 4001 is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, ensuring versatility in clinical use. Proper technique in insertion and handling is essential to maximize its benefits and minimize complications.
Frequently Asked Questions
What is the Safecross Vascular Introducer System 4001 used for?
It is used to facilitate vascular access during procedures such as embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for facilitating vascular access during procedures requiring catheter-based interventions.
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.