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watchman fxd curve access system
Boston Scientific
Summary: The Watchman FXD Curve Access System is a medical device used to facilitate the placement of venous stents. It is primarily used by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K212228 ↗
Decision Date
August 13, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Watchman FXD Curve Access System was cleared through the FDA 510k pathway on August 13, 2021. Manufactured by Boston Scientific, it is classified as a Class 2 device.
What It Is
The Watchman FXD Curve Access System is designed to aid in the delivery and placement of venous stents. It features a specialized curve to navigate the vascular anatomy efficiently. This device is particularly useful in procedures requiring precise access to venous structures, enhancing the clinician's ability to deploy stents accurately.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is particularly beneficial in procedures involving patients with venous obstructions or conditions requiring stent placement, such as chronic venous insufficiency. The system is utilized in hospitals and specialized cardiac centers, catering to adult patients with specific vascular needs.
Indications for Use
The FDA-cleared indications for the Watchman FXD Curve Access System involve its use in procedures that require venous stent placement. It is intended for patients who need improved venous blood flow due to blockages or other vascular conditions.
Practical Considerations
The Watchman FXD Curve Access System is compatible with a range of stent sizes, allowing for flexibility in various clinical scenarios. Clinicians should be familiar with the device's handling and navigation techniques to optimize procedural outcomes.
Frequently Asked Questions
What is the Watchman FXD Curve Access System used for?
It is used to facilitate the placement of venous stents in patients with vascular conditions requiring improved blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stent placement to improve blood flow in patients with vascular obstructions.
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.