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itg vascular access system model 300
Arstasis
Summary: The itg vascular access system model 300 by Arstasis is a medical device used for vascular access during interventional procedures. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K091006 ↗
Decision Date
February 25, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The itg vascular access system model 300 was cleared through the FDA 510(k) pathway on February 25, 2010. Manufactured by Arstasis, it is classified as a Class 2 device under product code DYB.
What It Is
The itg vascular access system model 300 is a device designed to facilitate vascular access for interventional procedures. It is specifically engineered to provide a stable and secure entry point into the vascular system, minimizing complications associated with traditional access methods. The system typically includes a sheath and other components that assist in achieving and maintaining vascular access.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as angiography, embolization, and other interventional radiology or cardiology procedures. It is particularly useful in settings where precise and stable vascular access is critical, such as in hospitals or specialized outpatient centers. The device is suitable for adult patients requiring these interventions.
Indications for Use
The FDA-cleared indications for the itg vascular access system model 300 include its use in procedures that require vascular access, such as the placement of embolization coils. It is intended for patients who need interventional procedures involving the vascular system.
Practical Considerations
Clinicians should consider the typical sizing options available for the itg vascular access system model 300 to ensure compatibility with the patient's vascular anatomy. Proper technique and familiarity with the device are important to optimize outcomes and minimize complications.
Frequently Asked Questions
What is itg vascular access system model 300 used for?
It is used for achieving and maintaining vascular access during interventional procedures, such as angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, including the placement of embolization coils.
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.