đź“‹ FDA Reference
spectranetics quick-cross extreme support catheters
Spectranetics
Summary: The Spectranetics Quick-Cross Extreme Support Catheters are used in vascular procedures to provide support and facilitate the delivery of other devices. They are typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K082561 ↗
Decision Date
December 10, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectranetics Quick-Cross Extreme Support Catheters were cleared through the FDA 510(k) pathway on December 10, 2008. Manufactured by Spectranetics, this Class 2 device is categorized under product code DQY.
What It Is
The Spectranetics Quick-Cross Extreme Support Catheters are specialized catheters designed to provide enhanced support during vascular interventions. These catheters are used to help navigate through difficult vascular pathways and facilitate the delivery of other therapeutic devices, such as stents or balloons, in the treatment of vascular conditions. Their design allows for improved pushability and trackability, which are crucial in complex procedures.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology settings, particularly during procedures involving the placement of venous stents. They are essential in cases where vascular access is challenging, such as in patients with tortuous or narrowed vessels. The device is suitable for use in both hospital and outpatient settings, catering to adult patients with peripheral vascular disease or other related conditions.
Indications for Use
The FDA-cleared indications for the Spectranetics Quick-Cross Extreme Support Catheters include use in procedures requiring vascular access and support for the delivery of other devices. This is particularly relevant for patients undergoing stent placements or other interventions in the venous system.
Practical Considerations
When using the Spectranetics Quick-Cross Extreme Support Catheters, clinicians should consider the appropriate sizing to match the patient's vascular anatomy. The catheters are compatible with a range of guidewires and other interventional tools, making them versatile in various procedural contexts. Proper technique in handling and insertion is crucial to maximize the device's effectiveness and minimize complications.
Frequently Asked Questions
What is Spectranetics Quick-Cross Extreme Support Catheters used for?
The device is used to provide support and facilitate the delivery of therapeutic devices during vascular interventions, such as stent placements.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access and support for the delivery of other devices, particularly in the venous system.
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.