đź“‹ FDA Reference
safe-cross deflecting catheter model c118nd1
Intra Luminal Therapeutics
Summary: The Safe-Cross Deflecting Catheter is a medical device used 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
K040481 ↗
Decision Date
March 18, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Safe-Cross Deflecting Catheter, manufactured by Intra Luminal Therapeutics, received FDA clearance via the 510k pathway on March 18, 2004. 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. Its deflecting tip allows for precise navigation through complex vascular pathways, enhancing the ability to reach and treat obstructed or narrowed veins. This device is particularly useful in procedures where standard catheters may struggle to access the target area.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly beneficial in cases of chronic venous insufficiency or post-thrombotic syndrome, where precise stent placement is critical. The device is suitable for use in both hospital and outpatient settings, catering to adult patients with venous obstructions.
Indications for Use
The FDA-cleared indications for the Safe-Cross Deflecting Catheter involve its use in procedures requiring venous stent placement. It is intended for patients with conditions such as venous obstructions or chronic venous insufficiency, where precise catheter navigation is necessary.
Practical Considerations
The Safe-Cross Deflecting Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and stents used in venous interventions. Clinicians should be familiar with catheter manipulation techniques to maximize its deflecting capabilities.
Frequently Asked Questions
What is the Safe-Cross Deflecting Catheter used for?
It is used for navigating and placing stents in venous structures during interventional procedures.
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 venous stenting procedures, particularly for patients with venous obstructions or chronic venous insufficiency.
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.