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premere delivery sheath model pds
Velocimed
Summary: The Premere Delivery Sheath Model PDS by Velocimed is a medical device used in embolization procedures. It is primarily utilized by interventional radiologists and cardiologists to deliver embolization coils to target sites within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K043084 ↗
Decision Date
May 2, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Premere Delivery Sheath Model PDS was cleared through the FDA 510k pathway on May 2, 2005. Manufactured by Velocimed, it is classified as a Class 2 device under product code DYB.
What It Is
The Premere Delivery Sheath Model PDS is a specialized catheter designed to facilitate the delivery of embolization coils. It is used in minimally invasive procedures to occlude blood vessels, thereby preventing blood flow to certain areas. The sheath provides a conduit through which coils can be precisely placed at the target site, ensuring effective embolization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring vascular embolization. It is particularly useful in treating aneurysms, arteriovenous malformations, and other conditions where blood flow needs to be controlled or stopped. The sheath is typically used in hospital settings, catering to adult and pediatric patients requiring endovascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in delivering embolization coils to occlude blood vessels. It is intended for patients requiring vascular embolization, such as those with aneurysms or abnormal blood vessel formations.
Practical Considerations
The Premere Delivery Sheath is available in various sizes to accommodate different vascular anatomies. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is Premere Delivery Sheath used for?
It is used for delivering embolization coils to occlude blood vessels in procedures like treating aneurysms or arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for delivering embolization coils to occlude blood vessels, particularly in patients with vascular abnormalities.
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.