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pinnacle destination peripheral guiding sheath
Terumo Medical
Summary: The Pinnacle Destination Peripheral Guiding Sheath is a medical device used by interventional radiologists and vascular surgeons to facilitate the delivery of therapeutic devices during endovascular procedures. It is primarily used in peripheral vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K091329 ↗
Decision Date
May 29, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pinnacle Destination Peripheral Guiding Sheath was cleared via the FDA 510k pathway on May 29, 2009. Manufactured by Terumo Medical, this device is classified as Class 2 under product code DYB.
What It Is
The Pinnacle Destination Peripheral Guiding Sheath is a flexible, tube-like device designed to provide a conduit for other medical instruments during endovascular procedures. It is used to navigate through the vascular system to reach peripheral blood vessels. The sheath aids in the precise placement of embolization coils and other therapeutic devices, ensuring safe and effective treatment.
Clinical Applications
This device is commonly used in procedures involving embolization, where it assists in the delivery of coils to occlude blood vessels, often to treat aneurysms or arteriovenous malformations. It is typically employed in interventional radiology and vascular surgery settings, particularly in hospitals and specialized clinics. The sheath is suitable for adult patients requiring peripheral vascular interventions.
Indications for Use
The FDA-cleared indications for the Pinnacle Destination Peripheral Guiding Sheath include its use in facilitating the placement of embolization coils in peripheral blood vessels. It is intended for patients needing endovascular treatment of vascular abnormalities.
Practical Considerations
The Pinnacle Destination Peripheral Guiding Sheath comes in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of guidewires and embolization devices. Clinicians should be familiar with the sheath's handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Pinnacle Destination Peripheral Guiding Sheath used for?
It is used to facilitate the delivery of embolization coils and other therapeutic devices during peripheral vascular interventions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of embolization coils in peripheral blood vessels.
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.