đź“‹ FDA Reference
percor percutaneous introducer
Datascope
Summary: The Percor Percutaneous Introducer by Datascope is a medical device used to facilitate the introduction of catheters or other instruments into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K820834 ↗
Decision Date
April 14, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Percor Percutaneous Introducer was cleared through the FDA 510(k) pathway on April 14, 1982. Manufactured by Datascope, it is classified as a Class 2 device under product code DYB.
What It Is
The Percor Percutaneous Introducer is a medical device designed to provide a conduit for the insertion of catheters or other instruments into the vascular system. It typically consists of a sheath and dilator, which help in creating a stable access point in the blood vessel. This device is crucial in procedures requiring vascular access, ensuring minimal trauma to the vessel and reducing the risk of complications.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Percor Percutaneous Introducer is essential in procedures such as angiography, embolization, and catheter-based interventions. It is used in hospital settings, particularly in catheterization labs and interventional suites, and is suitable for adult and pediatric patients requiring vascular access.
Indications for Use
The FDA indications for the Percor Percutaneous Introducer include its use in facilitating the introduction of diagnostic or therapeutic devices into the vascular system. It is indicated for patients undergoing procedures that require vascular access, such as embolization or angiography.
Practical Considerations
The Percor Percutaneous Introducer comes in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the insertion technique to minimize vascular trauma.
Frequently Asked Questions
What is Percor Percutaneous Introducer used for?
It is used to facilitate the introduction of catheters or other instruments into the vascular system during procedures like angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of diagnostic or therapeutic devices into the vascular system for procedures requiring vascular access.
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.