đź“‹ FDA Reference
fast-cath tm intra-cardiac introducer
Daig
Summary: The Fast-Cath TM Intra-Cardiac Introducer is a medical 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
K973840 ↗
Decision Date
May 21, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath TM Intra-Cardiac Introducer, manufactured by Daig, received FDA clearance via the 510k pathway on May 21, 1998. It is classified as a Class 2 device under product code DYB.
What It Is
The Fast-Cath TM Intra-Cardiac Introducer is a sheath system designed to provide a stable and accessible pathway for catheters entering the heart. It typically consists of a sheath and dilator, allowing for smooth catheter introduction and exchange during cardiac procedures. This device is essential in procedures requiring precise catheter placement within the cardiac chambers.
Clinical Applications
This device is commonly used in electrophysiology labs and cardiac catheterization suites. It is essential in procedures such as electrophysiological studies, catheter ablations, and the placement of pacemaker leads. Cardiologists and electrophysiologists use this introducer to ensure safe and effective access to the heart, particularly in patients requiring diagnostic or therapeutic interventions.
Indications for Use
The Fast-Cath TM Intra-Cardiac Introducer is indicated for use in patients undergoing procedures that require catheter access to the heart. This includes conditions such as arrhythmias, where precise catheter placement is necessary for diagnosis or treatment.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of catheter types and is designed for ease of use, with features that facilitate smooth insertion and exchange. Clinicians should be familiar with the specific technique for introducer placement to minimize complications.
Frequently Asked Questions
What is the Fast-Cath TM Intra-Cardiac Introducer used for?
It is used to facilitate the insertion and exchange of catheters into the heart during cardiac procedures.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac catheterization and electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for procedures requiring catheter access to the heart, such as those involving arrhythmias.
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.