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spectranetics 0 035 support catheter model 518-028
Spectranetics
Summary: The Spectranetics 0.035 Support Catheter is a medical device used primarily in vascular procedures to provide support and facilitate the delivery of other devices. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K022138 ↗
Decision Date
September 23, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectranetics 0.035 Support Catheter was cleared through the FDA 510(k) pathway on September 23, 2002. Manufactured by Spectranetics, it is classified as a Class 2 device under product code DQY.
What It Is
The Spectranetics 0.035 Support Catheter is a flexible, tubular device designed to provide support and stability within the vascular system during interventional procedures. It helps guide and position other medical devices, such as stents or guidewires, within blood vessels. Its design allows for navigation through complex vascular pathways, making it a crucial tool in endovascular interventions.
Clinical Applications
This support catheter is commonly used in procedures involving the placement of venous stents, particularly in cases of venous obstructions or stenosis. Interventional radiologists and cardiologists use it in hospital settings, often in catheterization labs, to treat patients with peripheral vascular disease or other vascular conditions. It is especially useful in patients requiring precise device placement in challenging vascular anatomies.
Indications for Use
The device is indicated for use in patients requiring support during the placement of stents or other devices in the venous system. It is particularly beneficial for those with narrowed or obstructed veins that need intervention to restore proper blood flow.
Practical Considerations
The catheter typically comes in various lengths and diameters to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and other interventional devices. Clinicians should be familiar with the catheter's handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the Spectranetics 0.035 Support Catheter used for?
It is used to provide support and facilitate the delivery of stents and other devices during vascular interventions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in supporting the placement of stents and other devices in the venous system, particularly in cases of venous obstruction or stenosis.
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.