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safe-cross deflecting catheter model c114nd1
Intra Luminal Therapeutics
Summary: The Safe-Cross Deflecting Catheter Model C114ND1 is a medical device used primarily in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to navigate and treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K031692 ↗
Decision Date
August 22, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Safe-Cross Deflecting Catheter received FDA clearance through the 510(k) pathway on August 22, 2003. Manufactured by Intra Luminal Therapeutics, it is classified as a Class 2 device under product code DQY.
What It Is
The Safe-Cross Deflecting Catheter is a specialized catheter designed to assist in the placement of stents within venous structures. It features a deflecting tip that aids in navigating through complex vascular anatomy, allowing for precise stent deployment. This device is particularly useful in cases where traditional catheters may struggle to access difficult-to-reach areas.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings for the treatment of venous obstructions, such as those found in patients with chronic venous insufficiency or post-thrombotic syndrome. It is particularly useful in procedures requiring precise navigation and stent placement in tortuous or occluded venous pathways. The device is suitable for adult patients who require venous stenting to restore adequate blood flow.
Indications for Use
The FDA-cleared indications for the Safe-Cross Deflecting Catheter involve its use in facilitating the placement of venous stents. It is intended for patients with conditions that lead to venous blockages, requiring intervention to improve vascular patency.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with various stent systems and its availability in multiple sizes to accommodate different patient anatomies. Proper technique in handling the deflecting tip is crucial for successful navigation and stent deployment. Familiarity with the device's operation can enhance procedural efficiency and outcomes.
Frequently Asked Questions
What is the Safe-Cross Deflecting Catheter used for?
It is used to assist in the placement of stents within venous structures, particularly in complex or obstructed pathways.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating venous stent placement in patients with 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.