đź“‹ FDA Reference
headway 21 microcatheter model mc212150s
Microvention
Summary: The Headway 21 Microcatheter is a device used in neurovascular procedures, primarily for the delivery of therapeutic agents or devices. It is typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K093160 ↗
Decision Date November 5, 2009
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Headway 21 Microcatheter, manufactured by Microvention, received FDA clearance via the 510(k) pathway on November 5, 2009. It is classified as a Class 2 medical device under product code DQY.
What It Is
The Headway 21 Microcatheter is a small, flexible catheter designed for navigating the intricate vasculature of the brain. It is used to deliver embolic agents or devices to treat conditions such as aneurysms or arteriovenous malformations. Its design allows for precise navigation through the tortuous pathways of the neurovascular system, minimizing trauma to the vessel walls.
Clinical Applications
This microcatheter is commonly used in interventional neuroradiology and neurosurgery settings. It is particularly useful in procedures requiring the delivery of coils or stents within the cerebral vasculature. Patients who benefit from this device often have conditions like cerebral aneurysms, where precise delivery of therapeutic agents is critical.
Indications for Use
The FDA indications for the Headway 21 Microcatheter include its use in delivering therapeutic devices or agents in the neurovascular system. It is suitable for patients with conditions requiring endovascular intervention, such as aneurysms or other vascular abnormalities.
Practical Considerations
The Headway 21 Microcatheter is typically available in various lengths and diameters to accommodate different procedural needs. It is compatible with a range of guidewires and embolic devices. Clinicians should be familiar with its handling characteristics to ensure optimal performance during procedures.
Frequently Asked Questions
What is the Headway 21 Microcatheter used for?
It is used for delivering therapeutic agents or devices in neurovascular procedures, such as treating aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for the delivery of therapeutic devices or agents within the neurovascular system, particularly for conditions like aneurysms.
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.