đź“‹ FDA Reference
reprocessed steerable introducer
Stryker Sustainability Solutions
Summary: The reprocessed steerable introducer is a medical device used to facilitate the placement of embolization coils in vascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K123334 ↗
Decision Date
January 24, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The reprocessed steerable introducer by Stryker Sustainability Solutions was cleared through the FDA 510(k) pathway on January 24, 2013. It is classified as a Class 2 device under product code DYB.
What It Is
The reprocessed steerable introducer is a device designed to aid in the precise placement of embolization coils within the vasculature. It features a steerable tip that allows clinicians to navigate complex vascular anatomy with improved control. This device is reprocessed to ensure cost-effectiveness and sustainability while maintaining safety and performance standards.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving embolization, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings where precise navigation through tortuous or challenging vascular pathways is required. Typical patient populations include those with vascular abnormalities or conditions requiring targeted embolization.
Indications for Use
The FDA indications for this device include its use in facilitating the placement of embolization coils. It is intended for patients requiring embolization procedures to treat vascular conditions like aneurysms or abnormal blood vessel formations.
Practical Considerations
Clinicians should consider the compatibility of the steerable introducer with other devices used in embolization procedures. Typical sizing options may vary, so it's important to select the appropriate size for the patient's anatomy. Proper technique in steering and positioning the device is crucial for successful outcomes.
Frequently Asked Questions
What is the reprocessed steerable introducer used for?
It is used to facilitate the placement of embolization coils in vascular procedures, allowing for precise navigation and positioning.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures involving vascular embolization.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of embolization coils in patients requiring embolization procedures for 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.