đź“‹ FDA Reference
Eagleray Long Sheath 0 088 ID 80cm 90cm 100cm and 110cm Lengths Eagleray Access Catheter 0 071 ID 137cm Length Eagleray Access Catheter 0 055 ID 137cm Length Eagleray Access Catheter 0 045 ID 144cm Length Eagleray Access Catheter 0 035 ID 158cm Length
Product: TracStar Large Distal Platform — all models and sizes
Summary: The EagleRay Access Devices are a series of sheaths and catheters used primarily in vascular procedures, particularly for venous stenting. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180169 ↗
Decision Date ?
August 8, 2018
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The EagleRay Access Devices were cleared through the FDA 510(k) pathway on August 8, 2018, by Imperative Care. These devices are classified as Class 2 under product code DQY.
What It Is
The EagleRay Access Devices include long sheaths and access catheters of various diameters and lengths, designed to facilitate the placement of venous stents. These devices are used to provide stable access to the vascular system, allowing for the precise delivery of therapeutic devices. The sheaths and catheters are engineered to navigate the vascular anatomy with minimal trauma.
FDA-Cleared Indications
- Percutaneous access to the vascular system during endovascular procedures.
- Facilitation of the introduction and placement of interventional devices within blood vessels.
- Use in patients requiring vascular access for procedures such as venous stent delivery, when selected by the treating physician.
Clinical Applications
- Providing vascular access for endovascular treatment of venous obstruction.
- Facilitating delivery of venous stents in iliac or central venous procedures.
- Maintaining a conduit for compatible catheters and therapeutic devices during venous interventions.
Practical Considerations
- The EagleRay long sheath has a 0.088-inch inner diameter and is available in 80, 90, 100, and 110 cm lengths.
- The access catheters include 0.071-inch inner diameter and 137 cm length; 0.055-inch inner diameter and 137 cm length; 0.045-inch inner diameter and 144 cm length; and 0.035-inch inner diameter and 158 cm length options.
- The selected diameter and length must be compatible with the guidewire, catheter, stent, and other devices used in the procedure, as well as the patient's vascular anatomy.
- The FDA record or supplied labeling should be checked for MRI compatibility, contrast-media requirements, and detailed contraindications; MRI safety should not be assumed from the device name alone.
- Potential access-related complications include bleeding, hematoma, vessel injury, thrombosis, infection, embolization, and contrast-related complications. Use is determined by a qualified clinician after assessment of risks and benefits.
Procedures that use this device
Frequently Asked Questions
What is EagleRay used for?
EagleRay devices are used to facilitate venous stenting procedures by providing stable vascular access.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use EagleRay devices.
What are the FDA-cleared indications?
The devices are indicated for use in procedures requiring vascular access for venous stenting.
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.