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
Imperative Care
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
510K
Number
K180169 ↗
Decision Date
August 8, 2018
Product Code
DQY
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.
Clinical Applications
These devices are commonly used in procedures requiring venous access, such as the placement of stents in the treatment of venous obstructions. They are particularly useful in interventional radiology and vascular surgery settings. The devices cater to a wide range of patient populations, including those with chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA-cleared indications for the EagleRay Access Devices involve their use in facilitating venous stenting procedures. They are intended for patients requiring vascular access for the treatment of venous conditions.
Practical Considerations
The EagleRay Access Devices come in various sizes to accommodate different anatomical needs, with sheath lengths ranging from 80cm to 110cm and catheter lengths from 137cm to 158cm. Clinicians should consider the compatibility of these devices with other procedural equipment and the specific vascular anatomy of the patient.
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.