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aries peel away percutaneous catheter introducer
Aries Medical
Summary: The Aries Peel Away Percutaneous Catheter Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is typically used by interventional radiologists and cardiologists in various vascular procedures.
FDA Clearance Information
Pathway
510K
Number
K871140 ↗
Decision Date
April 22, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Aries Peel Away Percutaneous Catheter Introducer was cleared through the FDA 510(k) pathway on April 22, 1987. Manufactured by Aries Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Aries Peel Away Percutaneous Catheter Introducer is designed to aid in the percutaneous insertion of catheters into blood vessels. It features a peel-away sheath that simplifies the process of catheter placement by allowing the sheath to be removed without dislodging the catheter. This device is particularly useful in procedures requiring stable and precise catheter positioning.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, central venous access, and other vascular interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The device is used in adult and pediatric populations requiring vascular access.
Indications for Use
The Aries Peel Away Percutaneous Catheter Introducer is indicated for use in patients requiring catheterization for vascular access. It is suitable for conditions where stable catheter placement is necessary, such as during embolization procedures.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters, ensuring compatibility with a wide range of catheters. Clinicians should be familiar with the peel-away technique to minimize the risk of catheter dislodgement during sheath removal.
Frequently Asked Questions
What is the Aries Peel Away Percutaneous Catheter Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels, commonly in vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring catheterization for vascular access, such as during embolization procedures.
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.