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pinnacle destination peripheral guiding sheath
Terumo Medical
Summary: The Pinnacle Destination Peripheral Guiding Sheath is a medical device used to facilitate the introduction of interventional devices into the peripheral vasculature. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K051601 ↗
Decision Date
August 4, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle Destination Peripheral Guiding Sheath was cleared through the FDA 510(k) pathway on August 4, 2005. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Pinnacle Destination Peripheral Guiding Sheath is a catheter-like device designed to provide a conduit for the delivery of interventional tools into the peripheral blood vessels. It features a flexible, kink-resistant design that aids in navigating tortuous vascular anatomy. The sheath is used to support the insertion of various devices such as embolization coils, stents, or balloons during vascular procedures.
Clinical Applications
This device is commonly used in procedures involving the peripheral vasculature, such as embolization, angioplasty, or stent placement. Interventional radiologists and vascular surgeons often use it in hospital settings, particularly in catheterization labs. It is suitable for adult patients requiring peripheral vascular interventions, including those with peripheral artery disease or vascular malformations.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the introduction of diagnostic or therapeutic devices into the peripheral vasculature. It is intended for patients undergoing procedures that require access to peripheral blood vessels.
Practical Considerations
The Pinnacle Destination Peripheral Guiding Sheath is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of interventional devices and requires careful handling to maintain sterility and prevent vessel trauma during insertion.
Frequently Asked Questions
What is the Pinnacle Destination Peripheral Guiding Sheath used for?
It is used to facilitate the introduction of interventional devices into the peripheral vasculature during procedures such as embolization or angioplasty.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of diagnostic or therapeutic devices into the peripheral vasculature.
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.