đź“‹ FDA Reference

excelsior sl-10 microcatheter models 168581 168381 168181 168189

Boston Scientific, Target

Summary: The Excelsior SL-10 microcatheter is a device used primarily in neurovascular procedures for the delivery of therapeutic agents or devices. It is typically used by interventional radiologists and neurosurgeons.

FDA Clearance Information

Pathway 510K
Decision Date December 6, 2001
Product Code DQY
Device Class Class 2
Evidence 0 studies

The Excelsior SL-10 microcatheter was cleared through the FDA 510(k) pathway on December 6, 2001. Manufactured by Boston Scientific, it is classified as a Class 2 medical device under product code DQY.

What It Is

The Excelsior SL-10 microcatheter is a small, flexible catheter designed for use in the neurovascular system. It allows for precise navigation through the intricate vasculature of the brain to deliver embolic agents or stents. Its design facilitates access to distal vessels, making it a critical tool in endovascular procedures.

Clinical Applications

This microcatheter is commonly used in procedures such as coil embolization for aneurysms or arteriovenous malformations (AVMs). It is utilized in interventional neuroradiology and neurosurgery settings, particularly in hospitals with advanced neurointerventional capabilities. The device is suitable for adult patients requiring endovascular treatment of complex vascular conditions.

Indications for Use

The FDA indications for the Excelsior SL-10 microcatheter involve its use in the delivery of embolic agents or stents within the neurovascular system. It is indicated for patients with conditions such as cerebral aneurysms or AVMs that require endovascular intervention.

Practical Considerations

The Excelsior SL-10 microcatheter is available in various lengths and diameters to accommodate different anatomical requirements. It is compatible with a range of guidewires and embolic materials. Clinicians should be skilled in microcatheter navigation techniques to optimize outcomes.

Frequently Asked Questions

What is the Excelsior SL-10 microcatheter used for?

It is used for delivering embolic agents or stents in neurovascular procedures, such as treating cerebral aneurysms or AVMs.

What specialties typically use this device?

Interventional radiologists and neurosurgeons commonly use this device in neurointerventional procedures.

What are the FDA-cleared indications?

The device is indicated for use in the delivery of embolic agents or stents within the neurovascular system, particularly for conditions like cerebral aneurysms and AVMs.

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.

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