đź“‹ FDA Reference
protector introducer sheath
Boston Scientific /International Technologies
Summary: The protector introducer sheath is a medical device used primarily in vascular procedures to facilitate the introduction of catheters and other devices. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K930808 ↗
Decision Date
March 15, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The protector introducer sheath was cleared through the FDA 510k pathway on March 15, 1994, by Boston Scientific/International Technologies. It is classified as a Class 2 device under product code DYB.
What It Is
The protector introducer sheath is a tubular device designed to provide a conduit for the insertion of catheters and other medical instruments into the vascular system. It helps maintain vascular access while minimizing trauma to the vessel. The sheath is typically made of biocompatible materials and may include features like hemostatic valves to prevent blood loss during procedures.
Clinical Applications
This device is commonly used in interventional procedures such as angiography, angioplasty, and embolization. It is essential in settings like catheterization labs and interventional radiology suites. The sheath is used in patient populations requiring vascular access for diagnostic or therapeutic interventions, including those with cardiovascular diseases.
Indications for Use
The FDA indications for the protector introducer sheath include its use in procedures requiring vascular access for the placement of catheters or other devices. It is suitable for patients undergoing interventions that involve the vascular system, such as embolization procedures.
Practical Considerations
The protector introducer sheath comes in various sizes to accommodate different vessel diameters and procedural needs. Compatibility with other devices, such as catheters and guidewires, is crucial, and clinicians should ensure proper sizing and technique to minimize complications like vessel trauma or bleeding.
Frequently Asked Questions
What is the protector introducer sheath used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures involving vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the placement of catheters or other medical devices.
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.