đź“‹ FDA Reference
splittable sheath introducer kit
Thomas Medical Products
Summary: The splittable sheath introducer kit is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K004025 ↗
Decision Date
July 19, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The splittable sheath introducer kit by Thomas Medical Products was cleared via the FDA 510(k) pathway on July 19, 2001. It is classified as a Class 2 device under product code DYB.
What It Is
The splittable sheath introducer kit is designed to provide a conduit for the insertion of catheters and other medical devices into the vascular system. It features a sheath that can be split and removed once the device is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring the insertion of embolization coils or other interventional devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise placement of coils or other occlusive devices is required. It is also utilized in settings where vascular access is necessary, such as in the placement of central venous catheters. The device is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The splittable sheath introducer kit is indicated for use in patients requiring the introduction of catheters or other devices into the vascular system. It is particularly useful in procedures involving embolization coils, providing a stable and safe method for device delivery.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with the splitting technique to ensure safe and effective removal of the sheath after device placement.
Frequently Asked Questions
What is the splittable sheath introducer kit used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, particularly in procedures like embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the introduction of catheters and other devices into the vascular system, especially in 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.