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fast-cath intra-cardiac introducer
Daig
Summary: The Fast-Cath Intra-Cardiac Introducer by Daig is a device used to facilitate the insertion of catheters into the heart. It is primarily used by cardiologists and electrophysiologists during cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K982187 ↗
Decision Date
September 16, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath Intra-Cardiac Introducer was cleared via the FDA 510(k) pathway on September 16, 1998. Manufactured by Daig, it is classified as a Class 2 medical device.
What It Is
The Fast-Cath Intra-Cardiac Introducer is a medical device designed to provide access to the heart for the insertion of catheters. It functions as a sheath that allows for the smooth and safe passage of diagnostic and therapeutic catheters into the cardiac chambers. This device is crucial in minimizing trauma to the vessel and cardiac tissue during catheter-based procedures.
Clinical Applications
Commonly used in electrophysiology labs and cardiac catheterization settings, the Fast-Cath Intra-Cardiac Introducer is essential for procedures such as electrophysiological studies, ablations, and the placement of pacemaker leads. It is used by cardiologists and electrophysiologists, particularly in patients requiring detailed cardiac mapping or intervention.
Indications for Use
The device is indicated for use in patients who require catheter-based access to the heart. This includes individuals undergoing diagnostic or therapeutic cardiac procedures, such as those with arrhythmias or structural heart disease.
Practical Considerations
The Fast-Cath Introducer is available in various sizes to accommodate different patient anatomies and catheter types. It is compatible with a range of catheter systems, and clinicians should ensure proper sizing and technique to minimize complications such as bleeding or vascular injury.
Frequently Asked Questions
What is the Fast-Cath Intra-Cardiac Introducer used for?
It is used to facilitate the insertion of catheters into the heart for diagnostic and therapeutic procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device during cardiac catheterization and electrophysiological procedures.
What are the FDA-cleared indications?
The device is indicated for providing access to the heart for catheter-based diagnostic and therapeutic procedures.
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.