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seal-away cs introducer kit models 407514 407515
St Jude Medical
Summary: The Seal-Away CS Introducer Kit is a medical device used for introducing catheters into the cardiovascular system. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K013029 ↗
Decision Date
October 9, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Seal-Away CS Introducer Kit, manufactured by St Jude Medical, was cleared via the FDA 510k pathway on October 9, 2001. It is a Class 2 device under product code DYB.
What It Is
The Seal-Away CS Introducer Kit is designed to facilitate the insertion of catheters into the cardiovascular system, particularly for procedures involving embolization coils. The kit typically includes a sheath and dilator, allowing for smooth and controlled access to the target site. Its design minimizes trauma to the vessel and ensures a secure seal to prevent blood loss during catheter insertion.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for procedures that require precise catheter placement in the coronary sinus or other cardiac structures. It is suitable for use in hospitals and specialized cardiac centers, catering to adult and pediatric patients who require embolization or other catheter-based interventions.
Indications for Use
The Seal-Away CS Introducer Kit is indicated for patients requiring catheter-based interventions in the cardiovascular system. It is particularly useful in procedures involving embolization coils, which are used to treat vascular abnormalities or block blood flow to certain areas.
Practical Considerations
The kit is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolization devices, and clinicians should ensure proper technique to maintain vascular access and minimize complications.
Frequently Asked Questions
What is the Seal-Away CS Introducer Kit used for?
It is used for introducing catheters into the cardiovascular system, particularly in procedures involving embolization coils.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device in hospital and specialized cardiac center settings.
What are the FDA-cleared indications?
The device is indicated for catheter-based interventions in the cardiovascular system, especially for procedures involving embolization coils.
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.