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remington medical dispos tear-away vasc intro set
Remington Medical
Summary: The Remington Medical Tear-Away Vascular Intro Set is a medical device used for vascular access procedures. It is typically utilized by interventional radiologists and cardiologists to facilitate the insertion of catheters or other devices into blood vessels.
FDA Clearance Information
Pathway
510K
Number
K932370 ↗
Decision Date
November 9, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on November 9, 1993, by Remington Medical. It is classified as a Class 2 device under product code DYB.
What It Is
The Remington Medical Tear-Away Vascular Intro Set is designed to provide a pathway for the insertion of catheters or other medical devices into the vascular system. It includes a tear-away sheath that allows for easy removal after the device is in place, minimizing trauma to the vessel. This set is particularly useful in procedures requiring precise vascular access.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures such as embolization, angiography, and central venous access. It is suitable for use in hospital settings, particularly in catheterization labs and operating rooms. The device is used in adult and pediatric populations requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The device is indicated for use in patients requiring vascular access for procedures such as embolization, where coils or other embolic agents are introduced to block blood flow to a specific area. It is suitable for patients needing precise and minimally invasive vascular interventions.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and patient needs. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the tear-away technique to ensure smooth removal of the sheath without damaging the vessel or device.
Frequently Asked Questions
What is the Remington Medical Tear-Away Vascular Intro Set used for?
It is used for gaining vascular access to facilitate the insertion of catheters or other devices during procedures like embolization or angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings for vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, particularly for embolization and other interventions requiring precise catheter placement.
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.