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amplatzer talisman delivery sheath
Abbott Medical
Summary: The Amplatzer Talisman Delivery Sheath is a medical device used for the delivery of venous stents. It is primarily used by interventional cardiologists and vascular surgeons in procedures requiring precise stent placement.
FDA Clearance Information
Pathway
510K
Number
K212738 ↗
Decision Date
September 27, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatzer Talisman Delivery Sheath was cleared through the FDA 510(k) pathway on September 27, 2021. Manufactured by Abbott Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Amplatzer Talisman Delivery Sheath is a specialized catheter designed to facilitate the delivery of venous stents. It provides a conduit for the stent to be accurately positioned within the venous system. The sheath is engineered to navigate complex vascular anatomy, offering flexibility and support during the stent deployment process.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, such as in the treatment of venous obstructions or insufficiencies. Interventional cardiologists and vascular surgeons use it in hospital settings, particularly in catheterization labs. It is suitable for adult patients with conditions that require venous stenting, such as chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Amplatzer Talisman Delivery Sheath include its use in procedures requiring the placement of venous stents. It is intended for patients with venous conditions that necessitate stenting to restore proper blood flow.
Practical Considerations
The sheath is available in various sizes to accommodate different patient anatomies and stent sizes. It is compatible with a range of stent types and requires careful handling to ensure accurate placement. Clinicians should be familiar with the device's operation and the specific technique for stent delivery.
Frequently Asked Questions
What is the Amplatzer Talisman Delivery Sheath used for?
It is used for the delivery and placement of venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents to treat venous conditions.
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.