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apeel cs catheter delivery system
St Jude Medical
Summary: The Apeel CS Catheter Delivery System is a medical device used for the delivery of embolization coils. It is primarily used by interventional radiologists and cardiologists in procedures to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K031906 ↗
Decision Date
July 18, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Apeel CS Catheter Delivery System was cleared through the FDA 510(k) pathway on July 18, 2003. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Apeel CS Catheter Delivery System is a specialized catheter designed to deliver embolization coils to targeted areas within the vascular system. It facilitates the precise placement of coils to occlude blood vessels, thereby treating conditions such as aneurysms or arteriovenous malformations. The system's design allows for controlled deployment and repositioning of coils, enhancing procedural accuracy and patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving the embolization of abnormal blood vessels. It is particularly useful in treating cerebral aneurysms, gastrointestinal bleeding, and pelvic congestion syndrome. The Apeel CS system is suitable for use in both hospital and outpatient settings, catering to adult and pediatric patient populations requiring vascular intervention.
Indications for Use
The FDA-cleared indications for the Apeel CS Catheter Delivery System include the delivery of embolization coils to occlude blood vessels. This is typically indicated for patients with vascular abnormalities such as aneurysms or arteriovenous malformations, where blood flow needs to be controlled or redirected.
Practical Considerations
Clinicians should consider the compatibility of the Apeel CS Catheter Delivery System with various coil sizes and types. Proper technique is essential for successful deployment, and practitioners should be trained in catheter-based interventions. The system is designed for single-use, minimizing the risk of cross-contamination.
Frequently Asked Questions
What is the Apeel CS Catheter Delivery System used for?
It is used for delivering embolization coils to occlude blood vessels in the treatment of vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils to occlude blood vessels, treating conditions like 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.