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introstat lead introducer
Msi
Summary: The Introstat Lead Introducer by Msi is a medical device used primarily by interventional radiologists and cardiologists to facilitate the insertion of leads or catheters into the vascular system. It is an essential tool in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K960200 ↗
Decision Date
July 2, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Introstat Lead Introducer was cleared through the FDA 510(k) pathway on July 2, 1996. Manufactured by Msi, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Introstat Lead Introducer is a specialized medical device designed to aid in the insertion of leads or catheters into the vascular system. It typically consists of a sheath and dilator that provide a stable pathway for the introduction of devices into blood vessels. This device is crucial in ensuring safe and efficient vascular access during various interventional procedures.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Introstat Lead Introducer is employed in procedures such as the placement of pacemaker leads, defibrillator leads, or other vascular catheters. It is particularly useful in hospital settings where precise vascular access is required, catering to adult and pediatric patient populations who need cardiac or vascular interventions.
Indications for Use
The FDA-cleared indications for the Introstat Lead Introducer include facilitating the insertion of leads or catheters into the vascular system. It is suitable for patients requiring vascular access for procedures like pacemaker or defibrillator implantation.
Practical Considerations
When using the Introstat Lead Introducer, clinicians should consider the appropriate size to match the patient's vascular anatomy. Compatibility with other vascular devices is crucial, and practitioners should be familiar with the insertion technique to minimize complications such as vascular trauma or infection.
Frequently Asked Questions
What is the Introstat Lead Introducer used for?
The Introstat Lead Introducer is used for facilitating the insertion of leads or catheters into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of leads or catheters into the vascular system, suitable for procedures like pacemaker or defibrillator implantation.
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.