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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitates the insertion of catheters into the heart during diagnostic or therapeutic cardiac procedures.
- Provides a stable access pathway for catheter placement and exchange within the cardiac chambers.
Clinical Applications
- Cardiac catheterization procedures requiring intracardiac catheter access.
- Electrophysiologic studies for evaluating cardiac rhythm disorders.
- Catheter-based treatment procedures in which intracardiac catheter placement is required.
- Placement or exchange of compatible cardiac catheters through an established access sheath.
Practical Considerations
- Available size and length options should be matched to the intended catheter, access route, and patient anatomy.
- The sheath and dilator are typically inserted over a guidewire using imaging guidance, with local anesthesia and sedation or other anesthesia as clinically appropriate.
- Use only with compatible catheters and accessories, following the device-specific instructions for use.
- MRI safety depends on the exact device configuration and whether the introducer remains in the patient; consult current labeling before MRI.
- Potential complications of intracardiac access include bleeding, hematoma, infection, vascular injury, arrhythmia, cardiac perforation, and pericardial effusion.
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.