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sublime microcatheter
Surmodics
Summary: The Sublime Microcatheter, manufactured by Surmodics, is a medical device used primarily in interventional radiology and vascular surgery for delivering stents in venous procedures. It is typically utilized by clinicians specializing in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K221886 ↗
Decision Date
October 14, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sublime Microcatheter was cleared through the FDA 510(k) pathway on October 14, 2022. It is manufactured by Surmodics and classified as a Class 2 device under product code DQY.
What It Is
The Sublime Microcatheter is a specialized catheter designed for the delivery of stents in venous systems. It features a flexible, small-diameter design that allows for navigation through complex vascular structures. The device is engineered to facilitate precise placement of stents, enhancing procedural efficiency and patient outcomes.
Clinical Applications
This microcatheter is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving venous stenting. It is suitable for use in hospitals and outpatient surgical centers, primarily by vascular surgeons and interventional radiologists. The device is often employed in treating patients with venous obstructions or insufficiencies.
Indications for Use
The FDA indications for the Sublime Microcatheter include its use in the placement of venous stents. It is intended for patients who require intervention for venous blockages or abnormalities, aiding in restoring proper blood flow.
Practical Considerations
The Sublime Microcatheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of stent types and requires careful handling to ensure optimal performance. Clinicians should be familiar with catheter navigation techniques to maximize its effectiveness.
Frequently Asked Questions
What is the Sublime Microcatheter used for?
The Sublime Microcatheter is used for delivering stents in venous procedures, aiding in the treatment of venous obstructions or abnormalities.
What specialties typically use this device?
This device is typically used by interventional radiologists and vascular surgeons.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of the device for the placement of venous stents to treat venous blockages or abnormalities.
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.