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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 commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K081046 ↗
Decision Date
May 21, 2008
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 May 21, 2008. It is manufactured by Terumo Medical and 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 introduction of interventional tools into the peripheral vascular system. It is typically composed of a flexible, kink-resistant material that allows for easy navigation through the vasculature. The sheath is used to maintain access to the vessel and facilitate the delivery of devices such as embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures requiring the placement of embolization coils to treat aneurysms or vascular malformations. The sheath provides stability and support for the delivery of these devices, making it suitable for use in patients with complex peripheral vascular conditions.
Indications for Use
The FDA-cleared indications for this device include use in procedures that require access to the peripheral vasculature, such as the delivery of embolization coils. It is intended for patients who need vascular interventions to address conditions like aneurysms or other vascular abnormalities.
Practical Considerations
The Pinnacle Destination Peripheral Guiding Sheath is available in various sizes to accommodate different vessel diameters. It is compatible with a range of interventional devices and should be selected based on the specific procedural requirements. Proper technique is essential to ensure successful navigation and placement within the vasculature.
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, such as during embolization procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring access to the peripheral vasculature, such as the delivery of embolization coils for treating vascular conditions.
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.