đź“‹ FDA Reference
modified peel-away introducer set line
Quinton
Summary: The Modified Peel-Away Introducer Set by Quinton is a Class 2 medical device used primarily for vascular access procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K864352 ↗
Decision Date
January 6, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Quinton, it is classified as a Class 2 device under product code DYB.
What It Is
The Modified Peel-Away Introducer Set is a medical device designed to facilitate the insertion of catheters into the vascular system. It features a sheath that can be peeled away once the catheter is in place, minimizing trauma to the vessel and allowing for smooth catheter placement. This device is particularly useful in procedures requiring temporary vascular access.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures such as the placement of central venous catheters or embolization coils. It is often employed in hospital settings, especially in intensive care units or during surgical interventions, to ensure reliable vascular access in patients requiring intravenous therapy or monitoring.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is suitable for conditions where temporary catheterization is necessary.
Practical Considerations
The introducer set typically comes in various sizes to accommodate different catheter diameters. It is compatible with a range of catheter types and is designed for ease of use, with a peel-away mechanism that simplifies the removal process. Clinicians should ensure proper sizing and technique to minimize complications.
Frequently Asked Questions
What is the Modified Peel-Away Introducer Set used for?
It is used to facilitate the insertion of catheters into the vascular system, particularly in procedures requiring temporary access.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device, especially in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in patients needing vascular access for diagnostic or therapeutic 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.