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fast-cath 18f hemostasis introducer model 406xxx
St. Jude Medical
Summary: The Fast-Cath 18F Hemostasis Introducer is a medical device used for vascular access during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K001367 ↗
Decision Date
May 31, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Fast-Cath 18F Hemostasis Introducer by St. Jude Medical was cleared via the FDA 510(k) pathway on May 31, 2000. It is classified as a Class II device under product code DYB.
What It Is
The Fast-Cath 18F Hemostasis Introducer is a vascular access device designed to facilitate the insertion of catheters and other instruments into the vascular system. It features a hemostatic valve to minimize blood loss during procedures. The device is typically used in interventional radiology and cardiology settings to provide a stable and secure entry point into blood vessels.
Clinical Applications
Commonly used in procedures such as embolization, angioplasty, and stent placement, the Fast-Cath 18F Hemostasis Introducer is essential for gaining access to the vascular system. It is frequently utilized in hospital settings, particularly in catheterization labs and interventional radiology suites. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The device is indicated for use in patients requiring vascular access for procedures like embolization and other interventional techniques. It is designed to facilitate the introduction of therapeutic devices into the vascular system safely.
Practical Considerations
The Fast-Cath 18F Hemostasis Introducer is compatible with a range of catheter sizes and is designed to minimize blood loss with its hemostatic valve. Clinicians should be familiar with the device's insertion technique to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Fast-Cath 18F Hemostasis Introducer used for?
It is used for vascular access during interventional procedures, such as embolization and angioplasty.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as embolization and other interventional techniques.
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.