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ptfe interlock peelable introducers
Enpath Medical
Summary: The PTFE Interlock Peelable Introducers are medical devices used to facilitate the insertion of catheters and other devices into the vascular system. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway 510K
Number K081394 ↗
Decision Date September 15, 2008
Product Code DYB
Device Class Class 2
Evidence 0 studies
The PTFE Interlock Peelable Introducers by Enpath Medical were cleared via the FDA 510k pathway on September 15, 2008. They are classified as Class 2 medical devices under product code DYB.
What It Is
PTFE Interlock Peelable Introducers are specialized introducer sheaths designed to aid in the insertion of catheters and other medical devices into the vascular system. Made from polytetrafluoroethylene (PTFE), these introducers feature a peelable sheath that can be easily removed once the device is in place, minimizing trauma to the vessel. Their design allows for a secure and efficient introduction of devices, reducing the risk of complications during procedures.
Clinical Applications
These introducers are commonly used in interventional radiology and cardiology for procedures such as the placement of embolization coils, central venous catheters, and other vascular interventions. They are particularly useful in settings where precise and safe vascular access is critical, such as in hospitals and specialized outpatient centers. The devices are suitable for a wide range of patient populations, including those requiring long-term vascular access or undergoing complex vascular procedures.
Indications for Use
The FDA-cleared indications for PTFE Interlock Peelable Introducers involve their use in facilitating the insertion of various medical devices into the vascular system. They are intended for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
Clinicians should consider the size of the introducer relative to the device being inserted to ensure compatibility. The peelable design allows for easy removal, which can be advantageous in minimizing vessel trauma. Familiarity with the technique for peeling and removing the sheath is important for optimal use.
Frequently Asked Questions
What is PTFE Interlock Peelable Introducers used for?
They are used to facilitate the insertion of catheters and other devices into the vascular system, minimizing trauma and ensuring secure placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of medical 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.