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morse hemostatic catheter introducer set
North American Instrument
Summary: The Morse Hemostatic Catheter Introducer Set is a medical device used for vascular access and hemostasis during interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K915078 ↗
Decision Date
June 10, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Morse Hemostatic Catheter Introducer Set was cleared through the FDA 510k pathway on June 10, 1992. Manufactured by North American Instrument, it is classified as a Class 2 device.
What It Is
The Morse Hemostatic Catheter Introducer Set is designed to facilitate the introduction of catheters into the vascular system while minimizing blood loss. It includes a hemostatic valve that helps maintain hemostasis during catheter exchanges. This device is essential in procedures requiring vascular access, providing a secure and efficient means to introduce and exchange catheters.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, angiography, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. Patients undergoing these procedures often have conditions requiring precise vascular access, such as aneurysms or vascular malformations.
Indications for Use
The FDA indications for this device include its use in procedures requiring vascular access and hemostasis. It is particularly beneficial for patients needing catheter-based interventions where blood loss must be minimized.
Practical Considerations
The Morse Hemostatic Catheter Introducer Set is available in various sizes to accommodate different catheter diameters. It is compatible with standard catheterization techniques and requires familiarity with vascular access procedures. Clinicians should ensure proper sizing and technique to optimize device performance.
Frequently Asked Questions
What is the Morse Hemostatic Catheter Introducer Set used for?
It is used for vascular access and hemostasis during interventional procedures, allowing for the introduction and exchange of catheters while minimizing blood loss.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access and hemostasis, particularly in catheter-based 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.