đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of embolization coils to a selected vascular site.
- Use in vascular embolization procedures where coils are placed to occlude or reduce blood flow.
Clinical Applications
- Catheter delivery of embolization coils during treatment of selected vascular abnormalities.
- Coil embolization of abnormal or bleeding blood vessels when the treating physician determines that coil occlusion is appropriate.
Practical Considerations
- The system is available in multiple models and sizes; the treating physician selects the appropriate catheter based on vessel diameter, anatomy and the intended coil.
- Placement is performed under fluoroscopic or other intravascular imaging guidance, usually through arterial access.
- Compatibility with the intended embolization coil, guidewire and delivery equipment should be confirmed before the procedure.
- As with other intravascular catheters, risks may include bleeding or hematoma at the access site, vessel injury, thrombosis, infection, non-target embolization and allergic reaction to contrast material.
- MRI safety and conditional labeling should be verified in the current manufacturer instructions for use; do not assume the catheter is safe during MRI solely because it is used before or after an MRI.
Procedures that use this device
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.