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pounce sheath
Surmodics
Summary: The Pounce Sheath by Surmodics is a medical device used in embolization procedures, typically by interventional radiologists. It is designed to facilitate the delivery of embolization coils to target sites within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K231828 ↗
Decision Date
September 7, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pounce Sheath was cleared through the FDA's 510(k) pathway on September 7, 2023. It is manufactured by Surmodics and classified as a Class 2 medical device.
What It Is
The Pounce Sheath is a specialized medical device used to assist in the delivery of embolization coils during vascular procedures. It functions as a conduit, allowing clinicians to navigate through the vascular system to deliver therapeutic agents precisely. This device is particularly useful in procedures where precise placement of embolization materials is critical to occlude blood vessels and control bleeding.
Clinical Applications
The Pounce Sheath is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures requiring embolization, such as treating aneurysms, arteriovenous malformations, or controlling hemorrhage. The device is suitable for use in hospitals and specialized clinics, primarily serving adult patients with vascular abnormalities or trauma.
Indications for Use
The FDA indications for the Pounce Sheath involve its use in delivering embolization coils to occlude blood vessels. This is applicable in patients needing vascular embolization to manage conditions like aneurysms or to stop bleeding.
Practical Considerations
The Pounce Sheath is available in various sizes to accommodate different vessel diameters and is compatible with standard embolization coils. Clinicians should be trained in vascular navigation techniques to ensure precise delivery and optimal outcomes.
Frequently Asked Questions
What is the Pounce Sheath used for?
The Pounce Sheath is used to deliver embolization coils to occlude blood vessels during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Pounce Sheath.
What are the FDA-cleared indications?
The FDA-cleared indications include delivering embolization coils to occlude blood vessels in procedures like aneurysm treatment or hemorrhage control.
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.