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ptfe super sheath introducer 2 1
Medcomp (Medical Components, Inc.)
Summary: The PTFE Super Sheath Introducer 2 1 by Medcomp is a medical device used primarily for vascular access in interventional procedures. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K153246 ↗
Decision Date
February 12, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Super Sheath Introducer 2 1 was cleared through the FDA 510(k) pathway on February 12, 2016. It is manufactured by Medcomp and classified as a Class 2 device under product code DYB.
What It Is
The PTFE Super Sheath Introducer 2 1 is a vascular access device designed to facilitate the introduction of catheters or other instruments into the vascular system. Made from polytetrafluoroethylene (PTFE), it provides a smooth, low-friction surface to minimize trauma during insertion. This device is particularly useful in procedures requiring the placement of embolization coils or other interventional tools.
Clinical Applications
Commonly used in interventional radiology and cardiology, the PTFE Super Sheath Introducer 2 1 is employed in procedures such as embolization, angiography, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites, and is used in patients requiring vascular access for therapeutic or diagnostic purposes.
Indications for Use
The device is indicated for use in patients needing vascular access for procedures involving embolization coils. It is suitable for conditions where precise catheter placement is necessary, such as in the treatment of vascular abnormalities or blockages.
Practical Considerations
The PTFE Super Sheath Introducer 2 1 is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolization devices. Clinicians should be familiar with insertion techniques to ensure optimal placement and minimize complications.
Frequently Asked Questions
What is the PTFE Super Sheath Introducer 2 1 used for?
It is used for vascular access in procedures requiring the insertion of catheters or embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures involving 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.