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safesheath msp introducer sheath kit with integral hemostasis valve
Thomas Medical Products
Summary: The SafeSheath MSP Introducer Sheath Kit is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K003731 ↗
Decision Date
April 10, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SafeSheath MSP Introducer Sheath Kit was cleared through the FDA 510(k) pathway on April 10, 2001. It is manufactured by Thomas Medical Products and classified as a Class 2 device under product code DYB.
What It Is
The SafeSheath MSP Introducer Sheath Kit is a vascular access device featuring an integral hemostasis valve designed to minimize blood loss during procedures. It provides a conduit for the introduction of catheters and other interventional tools into the vascular system. The sheath's design helps maintain hemostasis while allowing for smooth device exchanges.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as embolization, where precise delivery of coils or other embolic materials is required. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The device is often used in adult patients requiring vascular interventions.
Indications for Use
The SafeSheath MSP is indicated for use in procedures requiring vascular access, particularly where maintaining hemostasis is critical. It is suitable for patients undergoing embolization procedures, where controlled delivery of materials into the vascular system is necessary.
Practical Considerations
The SafeSheath MSP comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional devices. Clinicians should ensure proper sizing and compatibility with the intended procedural tools.
Frequently Asked Questions
What is the SafeSheath MSP Introducer Sheath Kit used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system while maintaining hemostasis.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
It is indicated for procedures requiring vascular access and hemostasis, such as embolization.
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.