đź“‹ FDA Reference
emcee introducer sheath dilator obturator introducer set
Schneider/Namic
Summary: The emcee introducer sheath dilator obturator introducer set is a medical device used to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used by interventional radiologists and cardiologists in various procedures.
FDA Clearance Information
Pathway
510K
Number
K980504 ↗
Decision Date
August 7, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The emcee introducer set by Schneider/Namic was cleared through the FDA 510k pathway on August 7, 1998. It is a Class 2 device under product code DYB.
What It Is
This device is a set comprising an introducer sheath, dilator, and obturator, designed to aid in the insertion of catheters into blood vessels. The sheath provides a stable conduit, while the dilator helps in gradually enlarging the vessel opening, minimizing trauma. The obturator is used to maintain the patency of the sheath during insertion.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential in procedures like angiography, embolization, and catheter-based interventions. It is particularly useful in settings where vascular access is required, such as in hospitals and specialized clinics, for patients needing diagnostic or therapeutic vascular procedures.
Indications for Use
The device is indicated for use in patients requiring vascular access for procedures like embolization. It is suitable for conditions where precise catheter placement is necessary, such as in the treatment of vascular anomalies or during diagnostic imaging.
Practical Considerations
The device comes in various sizes to accommodate different vessel diameters and is compatible with standard catheters. Clinicians should ensure proper sizing and technique to minimize vascular trauma and optimize procedural success.
Frequently Asked Questions
What is the emcee introducer sheath dilator obturator set used for?
It is used to facilitate the insertion of catheters into the vascular system during procedures like angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, particularly where catheter placement is required for diagnostic or therapeutic purposes.
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.