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procath locking peel-away introducer peel-away introducer set
Ep Medsystems
Summary: The Procath Locking Peel-Away Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is primarily used by interventional radiologists and cardiologists during procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K961513 ↗
Decision Date
May 13, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Procath Locking Peel-Away Introducer, manufactured by Ep Medsystems, was cleared by the FDA under 510k number K961513 on May 13, 1996. It is classified as a Class 2 device under product code DYB.
What It Is
The Procath Locking Peel-Away Introducer is a specialized medical tool designed to assist in the placement of catheters into blood vessels. It features a peel-away sheath that can be easily removed once the catheter is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring precise vascular access, such as the placement of central venous catheters or during embolization procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is essential for procedures that require reliable vascular access, such as the insertion of central venous catheters, pacemaker leads, or during embolization procedures. The device is suitable for use in both hospital and outpatient settings, and it is typically used in adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for the Procath Locking Peel-Away Introducer include facilitating the insertion of catheters into blood vessels. It is particularly indicated for patients requiring vascular access for procedures such as embolization or other interventional radiology techniques.
Practical Considerations
The Procath Locking Peel-Away Introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of catheter types and is designed to minimize vessel trauma during insertion. Clinicians should be familiar with the peel-away technique to ensure safe and effective use.
Frequently Asked Questions
What is the Procath Locking Peel-Away Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels, particularly in procedures requiring vascular access.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter insertion into blood vessels, especially in procedures like embolization.
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.