📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Transseptal puncture and introduction of catheters into the left atrium during cardiac procedures.
- Facilitation of percutaneous transseptal access through the interatrial septum.
Clinical Applications
- Obtaining left atrial access for catheter-based electrophysiology procedures.
- Providing transseptal access during atrial fibrillation ablation procedures.
- Introducing compatible cardiac catheters through the atrial septum in a catheterization or electrophysiology laboratory.
Practical Considerations
- The system should be used by clinicians trained in transseptal puncture and cardiac catheterization techniques.
- Sizing and compatibility must be matched to the intended catheter, sheath configuration, and patient anatomy.
- Transseptal puncture is generally performed with fluoroscopic and/or echocardiographic imaging guidance, often with local anesthesia and conscious sedation or general anesthesia depending on the procedure.
- Potential complications include cardiac perforation, pericardial effusion or tamponade, bleeding, thromboembolism, arrhythmia, and injury to adjacent structures.
- MRI safety status, including any conditions for MRI use, should be confirmed in the current manufacturer labeling before scanning; the device should not be assumed to be MRI safe.
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.