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ave gl-1 guiding catheter
Arterial Vascular Engineering Massachusetts
Summary: The ave gl-1 guiding catheter is used in vascular procedures to facilitate the placement of other devices. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K984482 ↗
Decision Date
July 30, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ave gl-1 guiding catheter was cleared through the FDA 510k pathway on July 30, 1999. It is manufactured by Arterial Vascular Engineering Massachusetts and classified as a Class 2 device.
What It Is
The ave gl-1 guiding catheter is a medical device designed to provide a conduit for the introduction of interventional devices into the vascular system. It is typically used in procedures requiring precise navigation through blood vessels, such as angioplasty or stent placement. The catheter is constructed to be flexible yet sturdy, allowing it to navigate the vascular anatomy effectively.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology and radiology for procedures such as coronary angiography, angioplasty, and the deployment of stents. It is suitable for use in both arterial and venous systems, making it versatile for various vascular interventions. The device is typically used in hospital settings, particularly in catheterization labs, and is applicable to adult patient populations undergoing vascular interventions.
Indications for Use
The FDA indications for the ave gl-1 guiding catheter include its use in facilitating the placement of other interventional devices within the vascular system. It is intended for patients requiring vascular access for procedures like angioplasty or stent deployment.
Practical Considerations
Clinicians should consider the catheter's compatibility with other devices and its sizing relative to the patient's vascular anatomy. Proper technique is essential for navigating the catheter through the vascular system, and it is important to ensure that the catheter is compatible with the specific interventional devices being used.
Frequently Asked Questions
What is the ave gl-1 guiding catheter used for?
The ave gl-1 guiding catheter is used to facilitate the placement of interventional devices within the vascular system, such as during angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in procedures involving vascular access and intervention.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of interventional devices within the vascular system for procedures like angioplasty and stent deployment.
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.