đź“‹ FDA Reference
usci mullins transseptal catheter intro
C.R. Bard
Summary: The USCI Mullins Transseptal Catheter Intro is a medical device used for transseptal access in cardiac procedures. It is primarily utilized by cardiologists and electrophysiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K791963 ↗
Decision Date
November 13, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The USCI Mullins Transseptal Catheter Intro was cleared through the FDA 510(k) pathway on November 13, 1979. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The USCI Mullins Transseptal Catheter Intro is a specialized catheter designed for transseptal puncture, allowing access to the left atrium from the right atrium. It facilitates various cardiac interventions, particularly those requiring precise navigation within the heart chambers. The catheter's design supports safe and effective crossing of the atrial septum.
Clinical Applications
This device is commonly used in procedures such as atrial fibrillation ablation, mitral valve repair, and left atrial appendage closure. It is predominantly used in cardiac catheterization labs by electrophysiologists and interventional cardiologists. The device is suitable for adult patients requiring transseptal access for diagnostic or therapeutic interventions.
Indications for Use
The device is indicated for use in patients needing transseptal access to the left atrium for various cardiac procedures. It is particularly beneficial in conditions requiring intervention within the left side of the heart.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard transseptal needles and sheaths. Clinicians should be trained in transseptal techniques to ensure safe and effective use.
Frequently Asked Questions
What is the USCI Mullins Transseptal Catheter Intro used for?
It is used for gaining transseptal access to the left atrium during cardiac procedures.
What specialties typically use this device?
Electrophysiologists and interventional cardiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for transseptal access to the left atrium for cardiac interventions.
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.