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pounce tm sheath
Surmodics
Summary: The Pounce TM Sheath by Surmodics is a medical device used in embolization procedures, primarily by interventional radiologists. It is designed to assist in the delivery of embolization coils to treat vascular conditions.
FDA Clearance Information
Pathway 510K
Number K252227 ↗
Decision Date September 24, 2025
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Pounce TM Sheath by Surmodics was cleared through the FDA's 510(k) pathway on September 24, 2025. It is classified as a Class 2 device under product code DYB.
What It Is
The Pounce TM Sheath is a specialized medical device used in interventional procedures to facilitate the delivery of embolization coils. It acts as a conduit, allowing for precise placement of coils within blood vessels to obstruct blood flow to specific areas, often to treat aneurysms or other vascular abnormalities. The sheath is designed to be compatible with various coil systems, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring embolization, such as treating cerebral aneurysms, arteriovenous malformations, or controlling bleeding. The sheath is used in hospital settings, typically in catheterization labs or interventional suites, and is applicable to a wide range of patient populations requiring vascular intervention.
Indications for Use
The FDA indications for the Pounce TM Sheath include its use in delivering embolization coils to occlude blood vessels. It is intended for patients with vascular conditions that require embolization, such as aneurysms or vascular malformations.
Practical Considerations
The Pounce TM Sheath is available in various sizes to accommodate different vessel diameters and is compatible with a range of embolization coils. Clinicians should be familiar with the specific technique for sheath insertion and coil deployment to ensure optimal outcomes. Proper training and experience in vascular access and embolization techniques are recommended.
Frequently Asked Questions
What is the Pounce TM Sheath used for?
The Pounce TM Sheath is used to deliver embolization coils into blood vessels to treat vascular conditions such as aneurysms.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Pounce TM Sheath in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of the sheath for delivering embolization coils to occlude blood vessels in patients with vascular 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.