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daig fast cath tm introducer modification
Daig
Summary: The Daig Fast Cath TM Introducer is a medical device used primarily for vascular access in interventional procedures. It is commonly used by cardiologists and interventional radiologists to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K914090 ↗
Decision Date
October 28, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Daig Fast Cath TM Introducer was cleared through the FDA 510(k) pathway on October 28, 1991. It is manufactured by Daig and classified as a Class 2 device under product code DYB.
What It Is
The Daig Fast Cath TM Introducer is a sheath introducer system designed to provide vascular access during interventional procedures. It consists of a sheath and a dilator, which allow for the smooth insertion of catheters into blood vessels. This device is essential for procedures requiring the introduction of diagnostic or therapeutic devices into the vascular system, ensuring minimal trauma to the vessel.
Clinical Applications
This device is commonly used in cardiac catheterization labs and interventional radiology suites. It is utilized in procedures such as angiography, angioplasty, and embolization, where precise vascular access is crucial. The introducer is suitable for adult patients undergoing these procedures, and it is used by specialists such as interventional cardiologists and radiologists.
Indications for Use
The FDA indications for the Daig Fast Cath TM Introducer include its use in facilitating the introduction of catheters and other devices into the vascular system. It is indicated for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Daig Fast Cath TM Introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheter sizes and types. Clinicians should be familiar with the technique for inserting the introducer to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Daig Fast Cath TM Introducer used for?
It is used for vascular access to facilitate the introduction of catheters and other devices during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in cardiac catheterization and interventional radiology procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of catheters and other devices into the vascular system for diagnostic or therapeutic purposes.
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.