đź“‹ FDA Reference
ptfe peelable introducer
Great Batch Medical
Summary: The PTFE Peelable Introducer by Great Batch Medical is a medical device used primarily for vascular access during procedures like embolization. It is utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K093023 ↗
Decision Date
October 29, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Peelable Introducer was cleared through the FDA 510(k) pathway on October 29, 2009. It is manufactured by Great Batch Medical and classified as a Class 2 device under product code DYB.
What It Is
The PTFE Peelable Introducer is a medical device designed to facilitate the insertion of catheters or other instruments into the vascular system. It features a peel-away sheath made of polytetrafluoroethylene (PTFE), which allows for smooth insertion and easy removal without disturbing the inserted device. This introducer is particularly useful in procedures requiring precise vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is crucial. It is suitable for use in hospital settings, particularly in catheterization labs or during minimally invasive surgeries. The introducer is typically used in adult patients requiring vascular interventions.
Indications for Use
The PTFE Peelable Introducer is indicated for use in procedures requiring vascular access, such as the placement of embolization coils. It is intended for patients who need precise and secure catheter insertion into the vascular system.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters, ensuring compatibility with a range of devices. Clinicians should be familiar with the peel-away technique to prevent complications during removal. It is important to select the appropriate size based on the procedure and patient anatomy.
Frequently Asked Questions
What is PTFE Peelable Introducer used for?
It is used for facilitating vascular access during procedures like embolization, allowing for the insertion of catheters or other instruments.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as the placement 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.