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Sublime Microcatheter
Product: Sublime Microcatheter, 035, 90cm, Angle — all models and sizes
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 ?
510(k)
Number ?
K221886 ↗
Decision Date ?
October 14, 2022
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Delivery and placement of venous stents during endovascular procedures, as specified by the applicable FDA-cleared labeling.
- Use in the peripheral venous system under fluoroscopic or other appropriate intravascular imaging guidance.
Clinical Applications
- Guiding and delivering a venous stent to a selected treatment location.
- Supporting endovascular treatment of clinically significant venous obstruction when venous stenting is indicated.
- Use during iliac or central venous stenting procedures when the catheter's labeled size and compatibility requirements are met.
Practical Considerations
- The available catheter sizes, working length, guidewire requirements and stent compatibility should be confirmed in the current manufacturer instructions for use before the procedure.
- The device is advanced through vascular access under fluoroscopic or other appropriate imaging guidance; careful wire and catheter manipulation is required to reduce the risk of vessel injury.
- Contraindications, warnings and precautions include situations in which venous catheterization or stent delivery is not appropriate, as well as inability to safely obtain vascular access.
- MRI safety depends on the complete device configuration and the manufacturer's current labeling. Do not assume that the catheter or a retained component is MRI safe without checking the applicable MR conditions.
- This is a sterile, single-use device. It is not intended to remain permanently in the body; the venous stent delivered by the catheter is a separate implant with its own duration and follow-up considerations.
Procedures that use this device
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.