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fast-cath hemostasis introducer and transseptal introducer
St Jude Medical
Summary: The Fast-Cath Hemostasis Introducer and Transseptal Introducer by St Jude Medical are used for vascular access and transseptal procedures. Primarily utilized by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K061015 ↗
Decision Date
August 3, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath Hemostasis Introducer was cleared via the FDA 510(k) pathway on August 3, 2006. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Fast-Cath Hemostasis Introducer is a medical device designed to facilitate vascular access and transseptal catheterization. It consists of a sheath and dilator that allow for the introduction of catheters into the vascular system. The device is engineered to minimize bleeding at the puncture site, ensuring hemostasis during and after the procedure.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures requiring vascular access, such as cardiac catheterization and electrophysiology studies. It is particularly useful in transseptal procedures where access to the left atrium is needed, such as in atrial fibrillation ablation. The device is suitable for adult patients requiring precise and controlled vascular access.
Indications for Use
The FDA-cleared indications for the Fast-Cath Hemostasis Introducer include facilitating vascular access and transseptal procedures. It is intended for use in patients undergoing procedures that require catheterization of the heart or other vascular structures.
Practical Considerations
The Fast-Cath Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, making it versatile for various procedures. Clinicians should be trained in transseptal techniques to ensure safe and effective use.
Frequently Asked Questions
What is the Fast-Cath Hemostasis Introducer used for?
It is used for vascular access and transseptal procedures, particularly in cardiac catheterization and electrophysiology studies.
What specialties typically use this device?
Cardiologists and interventional radiologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access and transseptal procedures in patients requiring catheterization.
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.