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seclusion catheter
Basis Medical
Summary: The seclusion catheter by Basis Medical is a Class 2 medical device used primarily in venous stenting procedures. It is designed for use by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K243436 ↗
Decision Date
February 28, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The seclusion catheter was cleared through the FDA 510k pathway on February 28, 2025. It is manufactured by Basis Medical and classified as a Class 2 device.
What It Is
The seclusion catheter is a specialized medical device used to facilitate the placement of venous stents. It is designed to navigate through the venous system, providing a pathway for stent delivery. The device's design allows for precise control and placement, minimizing trauma to the vessel walls.
Clinical Applications
This catheter is commonly used in procedures involving the treatment of venous obstructions or insufficiencies. It is particularly relevant in settings such as interventional radiology suites and vascular surgery centers. Patients with conditions like deep vein thrombosis or chronic venous insufficiency may benefit from procedures utilizing this device.
Indications for Use
The seclusion catheter is indicated for use in patients requiring venous stenting. This includes individuals with narrowed or blocked veins that need support to restore proper blood flow.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard venous stents and requires careful handling to ensure accurate placement. Clinicians should be trained in catheter-based interventions.
Related Literature
The linked study from 1991 investigated acid/base balance in conscious dogs using an indwelling catheter. Key findings included changes in arterial pH and blood gases related to feeding and time of day. While informative, the study's relevance to the seclusion catheter is limited due to differences in species and clinical application.
Frequently Asked Questions
What is the seclusion catheter used for?
It is used for delivering venous stents in procedures to treat venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stenting to address narrowed or blocked veins.
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.