đź“‹ FDA Reference
safecross transseptal puncture and introducer tsp i system
East End Medical I
Summary: The SafeCross Transseptal Puncture and Introducer TSP I System is a medical device used for transseptal access in cardiac procedures. It is primarily used by cardiologists and electrophysiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K203459 ↗
Decision Date
July 6, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SafeCross TSP I System was cleared through the FDA 510(k) pathway on July 6, 2021. Manufactured by East End Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The SafeCross Transseptal Puncture and Introducer TSP I System is designed to facilitate transseptal access to the left atrium of the heart. This system combines a puncture needle and an introducer sheath, allowing for precise and controlled entry through the atrial septum. It is particularly useful in procedures requiring left atrial access, such as catheter ablations and other electrophysiological interventions.
Clinical Applications
This device is commonly used in electrophysiology labs for procedures like atrial fibrillation ablation, where access to the left atrium is necessary. Cardiologists and electrophysiologists employ this system during catheter-based interventions, often in hospital settings. It is particularly relevant for patients with arrhythmias requiring ablation therapy.
Indications for Use
The SafeCross TSP I System is indicated for patients needing transseptal access for cardiac procedures. It is suitable for conditions requiring left atrial interventions, such as atrial fibrillation or other complex arrhythmias.
Practical Considerations
The device is compatible with standard cardiac catheterization equipment. Clinicians should be familiar with transseptal puncture techniques and ensure the device sizing matches patient anatomy. Proper training in its use is recommended to minimize complications.
Frequently Asked Questions
What is the SafeCross TSP I System used for?
It is used for transseptal access to the left atrium during cardiac procedures such as catheter ablations.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for transseptal access in cardiac procedures requiring left atrial intervention.
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.