đź“‹ FDA Reference
tear-away sheath introducer set with integral hemostasis valve
Thomas Medical Products
Summary: The tear-away sheath introducer set with integral hemostasis valve is a medical device used primarily in interventional procedures to facilitate the insertion of catheters or other devices into blood vessels. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K934901 ↗
Decision Date
January 21, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on January 21, 1994, by Thomas Medical Products. It is classified as a Class 2 device under product code DYB.
What It Is
The tear-away sheath introducer set is designed to aid in the insertion of catheters into the vascular system. It features an integral hemostasis valve that minimizes blood loss during procedures. The sheath can be 'torn away' after the catheter is in place, which simplifies removal and reduces trauma to the vessel.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the placement of embolization coils or other interventional devices. It is frequently utilized in settings like interventional radiology suites and cardiac catheterization labs. Patients undergoing procedures for conditions such as aneurysms or vascular malformations may benefit from its use.
Indications for Use
The device is indicated for use in facilitating the insertion of catheters into blood vessels, particularly in procedures involving embolization coils. It is suitable for patients requiring vascular interventions.
Practical Considerations
The sheath introducer comes in various sizes to accommodate different catheter dimensions. It is compatible with a range of interventional devices. Clinicians should be familiar with the technique of 'tearing away' the sheath to ensure safe and effective use.
Frequently Asked Questions
What is the tear-away sheath introducer set used for?
It is used to facilitate the insertion of catheters into blood vessels, particularly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters into blood vessels, particularly 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.