đź“‹ FDA Reference
concentric balloon guide catheter model 90072
Concentric Medical
Summary: The concentric balloon guide catheter model 90072 is a medical device used primarily in endovascular procedures to facilitate the placement of other devices. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K021899 ↗
Decision Date July 10, 2002
Product Code DQY
Device Class Class 2
Evidence 0 studies
The concentric balloon guide catheter model 90072 was cleared through the FDA 510(k) pathway on July 10, 2002. Manufactured by Concentric Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The concentric balloon guide catheter is a flexible tube with an inflatable balloon at its tip, designed to provide support and stability during endovascular procedures. It is inserted into the vascular system to guide and position other devices, such as stents or coils, with precision. The balloon can be inflated to temporarily occlude blood flow, aiding in the control of bleeding or in the placement of therapeutic devices.
Clinical Applications
This device is commonly used in procedures involving the cerebral and peripheral vasculature. Interventional radiologists and vascular surgeons use it in settings such as hospitals or specialized clinics to treat conditions like aneurysms or vascular malformations. It is particularly useful in patients requiring precise device placement or temporary blood flow occlusion during complex interventions.
Indications for Use
The FDA-cleared indications for this device include use in procedures requiring vascular access and guidance, particularly in the placement of venous stents. It is suitable for patients with vascular conditions needing endovascular intervention.
Practical Considerations
The concentric balloon guide catheter typically comes in various sizes to accommodate different vessel diameters. It is compatible with a range of guidewires and other endovascular tools. Clinicians should be trained in endovascular techniques to ensure proper use and placement.
Frequently Asked Questions
What is the concentric balloon guide catheter used for?
It is used to guide and support the placement of other endovascular devices, such as stents, during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons are the primary users of this device.
What are the FDA-cleared indications?
It is indicated for use in vascular procedures requiring guidance and support, particularly for the placement of venous stents.
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.