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ptfe peel away microintroducer
Intromed
Summary: The PTFE Peel Away Microintroducer by Intromed is a device used primarily in interventional radiology and cardiology for the insertion of catheters or other devices into the vascular system. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K072130 ↗
Decision Date
October 31, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Peel Away Microintroducer was cleared through the FDA 510k pathway on October 31, 2007, by Intromed. It is classified as a Class 2 device under the product code DYB.
What It Is
The PTFE Peel Away Microintroducer is a medical device designed to facilitate the insertion of catheters or other devices into the vascular system. It features a peel-away sheath made of polytetrafluoroethylene (PTFE), which allows for smooth insertion and removal while minimizing trauma to the vessel. The device is particularly useful in procedures requiring precise vascular access.
Clinical Applications
This device is commonly used in procedures such as the placement of embolization coils, central venous catheters, and other vascular interventions. It is frequently employed in interventional radiology and cardiology settings, where precise and minimally invasive access to the vascular system is required. Patients undergoing procedures for embolization or those requiring long-term vascular access are typical candidates.
Indications for Use
The FDA-cleared indications for the PTFE Peel Away Microintroducer include its use in facilitating the introduction of catheters and other devices into the vascular system. It is suitable for patients requiring vascular access for diagnostic or therapeutic purposes.
Practical Considerations
The PTFE Peel Away Microintroducer is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of guidewires and catheters, making it versatile for different procedural needs. Clinicians should be familiar with the peel-away technique to ensure safe and effective use.
Frequently Asked Questions
What is the PTFE Peel Away Microintroducer used for?
It is used to facilitate the insertion of catheters or other devices into the vascular system, often in interventional radiology and cardiology.
What specialties typically use this device?
Interventional radiologists and cardiologists are the primary users of this device.
What are the FDA-cleared indications?
It is indicated for the introduction of catheters and other devices into the vascular system for diagnostic or therapeutic purposes.
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.