đź“‹ FDA Reference
neuron delivery catheter 070
Penumbra
Summary: The Neuron Delivery Catheter 070 by Penumbra is a device used for delivering therapeutic agents or devices into the vascular system, primarily in neurovascular and peripheral vascular procedures. It is typically used by interventional radiologists and neurointerventionalists.
FDA Clearance Information
Pathway
510K
Number
K082290 ↗
Decision Date
October 31, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Neuron Delivery Catheter 070 was cleared through the FDA 510(k) pathway on October 31, 2008. Manufactured by Penumbra, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Neuron Delivery Catheter 070 is a specialized catheter designed to facilitate the delivery of therapeutic agents or devices into the vascular system. It features a flexible design that allows navigation through the complex vascular anatomy, making it particularly useful in neurovascular and peripheral vascular interventions. The catheter's design ensures stability and precision in device delivery, which is critical in delicate procedures.
Clinical Applications
This catheter is commonly used in neurointerventional procedures such as the treatment of cerebral aneurysms or arteriovenous malformations. It is also used in peripheral vascular interventions to deliver stents or embolic agents. The device is primarily utilized in hospital settings by specialists such as interventional radiologists and neurointerventionalists, who require precise navigation and delivery capabilities in complex vascular territories.
Indications for Use
The Neuron Delivery Catheter 070 is indicated for use in procedures requiring the delivery of therapeutic devices or agents into the vascular system. It is suitable for patients with conditions affecting the neurovascular or peripheral vascular systems, where precise device placement is necessary.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of guidewires and other interventional devices. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique to optimize outcomes.
Frequently Asked Questions
What is Neuron Delivery Catheter 070 used for?
It is used for delivering therapeutic agents or devices into the vascular system, particularly in neurovascular and peripheral vascular procedures.
What specialties typically use this device?
Interventional radiologists and neurointerventionalists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of therapeutic devices or agents into the vascular system, particularly for neurovascular and peripheral vascular conditions.
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.