đź“‹ FDA Reference
ccentermark catheter introducer shealth with protectiv 2000 needle safety system
Johnson & Johnson Medical
Summary: The Ccentermark Catheter Introducer Sheath with Protective 2000 Needle Safety System is a device used to facilitate the introduction of catheters into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K962978 ↗
Decision Date
January 7, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ccentermark Catheter Introducer Sheath was cleared through the FDA 510(k) pathway on January 7, 1997. Manufactured by Johnson & Johnson Medical, it is classified as a Class 2 medical device.
What It Is
The Ccentermark Catheter Introducer Sheath is a medical device designed to aid in the insertion of catheters into blood vessels. It includes a protective needle safety system to minimize the risk of needle-stick injuries. The device is typically used in procedures requiring vascular access, such as angiography or the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures that require vascular access. It is particularly useful in settings like hospitals and specialized clinics where minimally invasive procedures are performed. The sheath is suitable for a wide range of patient populations, including those undergoing diagnostic or therapeutic vascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in patients needing vascular access for procedures like embolization. It is suitable for conditions where catheter-based interventions are necessary.
Practical Considerations
The Ccentermark Catheter Introducer Sheath is available in various sizes to accommodate different catheter dimensions. It is compatible with standard catheter equipment and requires familiarity with vascular access techniques for optimal use.
Frequently Asked Questions
What is the Ccentermark Catheter Introducer Sheath used for?
It is used to facilitate the introduction of catheters into the vascular system, often in procedures like angiography or embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access, such as the introduction of embolization coils.
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.