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apeel cs plus catheter delivery system models 407579 407580 407581 407582
St. Jude Medical, Daig Division
Summary: The Apeel CS Plus Catheter Delivery System is a medical device used for delivering embolization coils in vascular procedures. It is primarily used by interventional radiologists and cardiologists to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K051096 ↗
Decision Date
May 17, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Apeel CS Plus Catheter Delivery System was cleared through the FDA 510k pathway on May 17, 2005. It is manufactured by St. Jude Medical, Daig Division, and is classified as a Class 2 device under product code DYB.
What It Is
The Apeel CS Plus Catheter Delivery System is designed to facilitate the delivery of embolization coils into the vascular system. It consists of a catheter that is navigated through the vasculature to the target site, where coils are deployed to occlude blood flow in abnormal vessels. This device is crucial in managing conditions such as aneurysms or arteriovenous malformations.
Clinical Applications
This catheter system is commonly used in interventional radiology and cardiology procedures to treat vascular abnormalities. It is particularly useful in embolization procedures where precise delivery of coils is required to occlude blood vessels. The device is used in hospital settings, primarily in catheterization labs, and is suitable for adult and pediatric patients with vascular conditions.
Indications for Use
The FDA-cleared indications for the Apeel CS Plus Catheter include the delivery of embolization coils to treat vascular abnormalities. This means it is used in patients who have conditions like aneurysms or arteriovenous malformations that require occlusion of blood vessels to prevent rupture or reduce blood flow.
Practical Considerations
The Apeel CS Plus Catheter is available in various sizes to accommodate different vessel diameters and patient anatomies. It is compatible with standard embolization coils and requires fluoroscopic guidance for accurate placement. Clinicians should be familiar with catheter navigation techniques to optimize outcomes.
Frequently Asked Questions
What is the Apeel CS Plus Catheter used for?
It is used for delivering embolization coils to occlude blood vessels in vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to treat vascular abnormalities such as aneurysms and arteriovenous malformations.
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.