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cardiodrive model 001-004115 non-sterile 001-1169-1 sterile
Stereotaxis
Summary: The Cardiodrive Model 001-004115 is a medical device used for the placement of venous stents. It is typically used by interventional cardiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K042850 ↗
Decision Date
August 9, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cardiodrive Model 001-004115 by Stereotaxis was cleared through the FDA 510(k) pathway on August 9, 2006. It is classified as a Class II device under product code DQY.
What It Is
The Cardiodrive Model 001-004115 is a device designed to assist in the placement of venous stents. It operates by providing precise control and navigation during stent deployment, which is crucial in maintaining patency in venous structures. This device is particularly useful in procedures requiring high precision, such as those involving complex vascular anatomy.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery for procedures involving the placement of stents in venous systems. It is particularly beneficial in settings where precision is paramount, such as in the treatment of venous obstructions or in patients with complex vascular conditions. The device is used in hospital catheterization labs and specialized vascular centers.
Indications for Use
The Cardiodrive is indicated for use in patients requiring venous stenting, such as those with venous obstructions or conditions like deep vein thrombosis. It is designed to facilitate the accurate placement of stents to ensure proper blood flow.
Practical Considerations
The device is available in both sterile and non-sterile versions, allowing for flexibility in various clinical settings. It is compatible with standard venous stents and requires familiarity with catheter-based techniques for optimal use. Clinicians should ensure proper sizing and compatibility with the patient's anatomy before use.
Frequently Asked Questions
What is Cardiodrive Model 001-004115 used for?
The Cardiodrive is used for the precise placement of venous stents in patients with venous obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is cleared for use in the placement of venous stents to treat conditions like venous obstructions.
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.