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spectranetics 0 014 support catheter model 518-016 spectranetics 0 018 support catheter model 518-017
Spectranetics
Summary: The Spectranetics 0.014 and 0.018 support catheters are used in vascular procedures, primarily by interventional cardiologists and radiologists. They facilitate the delivery of guidewires and other devices in venous interventions.
FDA Clearance Information
Pathway
510K
Number
K991059 ↗
Decision Date
November 16, 1999
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectranetics support catheters were cleared via the FDA 510(k) pathway on November 16, 1999. Manufactured by Spectranetics, these Class 2 devices fall under the product code DQY.
What It Is
The Spectranetics 0.014 and 0.018 support catheters are flexible, tubular devices designed to support the placement and exchange of guidewires and other interventional tools during vascular procedures. They are particularly useful in navigating complex venous anatomy and providing stability during interventions. The catheters are made to be compatible with a variety of guidewire sizes, enhancing their versatility in clinical settings.
Clinical Applications
These support catheters are commonly used in interventional cardiology and radiology for procedures involving venous stents. They are essential in cases where precise navigation through the venous system is required, such as in the treatment of venous occlusions or stenosis. The devices are typically used in hospital settings, catering to adult patients with complex vascular conditions.
Indications for Use
The FDA indications suggest these catheters are intended for use in procedures requiring venous stenting. They are suitable for patients with conditions like venous blockages or narrowing, where stent placement is necessary to restore proper blood flow.
Practical Considerations
These catheters are available in different sizes, typically 0.014 and 0.018 inches, to accommodate various guidewire diameters. Clinicians should ensure compatibility with other interventional devices and consider the catheter's flexibility and length when planning procedures.
Frequently Asked Questions
What is Spectranetics support catheter used for?
It is used to support the placement and exchange of guidewires and other devices during vascular procedures, particularly in venous interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The catheters are indicated for use in procedures requiring venous stenting, particularly in cases of venous occlusions 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.