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blunt t-peel introducer model number pe-16picb pe-18picb pe-20picb pe-24picb
Luther Medical Products
Summary: The blunt t-peel introducer is a medical device used to facilitate the insertion of embolization coils. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K982797 ↗
Decision Date
November 30, 1998
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The blunt t-peel introducer by Luther Medical was cleared through the FDA 510k pathway on November 30, 1998. It is a Class 2 device under product code DYB.
What It Is
The blunt t-peel introducer is a specialized medical device designed to aid in the placement of embolization coils within the vascular system. It features a peel-away sheath that allows for smooth insertion and removal without damaging the vessel. This device is particularly useful in procedures requiring precise coil deployment to block blood flow to specific areas, such as in the treatment of aneurysms or vascular malformations.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly during embolization procedures. It is suitable for patients requiring targeted embolization to treat conditions like aneurysms, arteriovenous malformations, or to control bleeding. The introducer is used in hospitals and specialized clinics where minimally invasive procedures are performed.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring the introduction of embolization coils. It is suitable for patients with conditions that benefit from controlled vascular occlusion, such as aneurysms or vascular malformations.
Practical Considerations
The blunt t-peel introducer comes in various sizes, typically ranging from 16 to 24 gauge, to accommodate different vessel sizes and coil dimensions. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be familiar with the peel-away technique to maximize the device's effectiveness.
Frequently Asked Questions
What is the blunt t-peel introducer used for?
It is used to facilitate the insertion of embolization coils during procedures that require vascular occlusion.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils, such as treating aneurysms or vascular malformations.
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.