đź“‹ FDA Reference
medtronic input ps introducer
Medtronic
Summary: The Medtronic Input PS Introducer is a medical device used primarily in embolization procedures. It is utilized by interventional radiologists and vascular surgeons to facilitate the introduction of embolization coils into the vasculature.
FDA Clearance Information
Pathway
510K
Number
K132617 ↗
Decision Date
April 30, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medtronic Input PS Introducer was cleared through the FDA 510(k) pathway on April 30, 2014. Manufactured by Medtronic, it is classified as a Class 2 device under product code DYB.
What It Is
The Medtronic Input PS Introducer is a specialized catheter designed to aid in the delivery of embolization coils into blood vessels. It provides a stable and flexible conduit for the precise placement of coils, which are used to occlude blood flow in targeted areas. This device is essential for procedures requiring high precision and control within the vascular system.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Medtronic Input PS Introducer is vital in embolization procedures to treat conditions such as aneurysms, arteriovenous malformations, and other vascular abnormalities. It is typically employed in hospital settings, particularly in catheterization labs and operating rooms, for adult and pediatric patients requiring vascular intervention.
Indications for Use
The device is indicated for use in procedures that require the introduction of embolization coils into the vasculature. It is suitable for patients needing vascular occlusion to manage abnormal blood flow or to treat vascular lesions.
Practical Considerations
The Medtronic Input PS Introducer comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of embolization coils and is designed for easy handling and maneuverability during procedures. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is Medtronic Input PS Introducer used for?
It is used to facilitate the introduction of embolization coils into the vasculature for occlusion of blood flow in targeted areas.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for procedures requiring the introduction of embolization coils into blood vessels to manage abnormal blood flow or treat vascular lesions.
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.