đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access during interventional procedures.
- Access for procedures involving the placement of embolization coils.
Clinical Applications
- Obtaining vascular access for catheter-based embolization procedures.
- Providing access for placement of embolization coils.
- Facilitating access during diagnostic or therapeutic angiographic procedures when consistent with the device labeling.
Practical Considerations
- Confirm that the selected system size and components are compatible with the planned catheter, guidewire, and vascular anatomy.
- Use sterile technique and fluoroscopic or other appropriate imaging guidance according to institutional practice and the device instructions for use.
- Review the current manufacturer labeling for contraindications, warnings, access-site requirements, and component compatibility.
- MRI safety information is not established by the FDA summary provided here; check the product labeling before MRI exposure.
- Potential vascular-access complications include bleeding, hematoma, infection, vessel injury, thrombosis, and pseudoaneurysm.
Procedures that use this device
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.