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 primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K092396 ↗
Decision Date
September 4, 2009
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 September 4, 2009. Manufactured by Spectranetics, this Class 2 device is used in vascular interventions.
What It Is
The Spectranetics Quick Cross Extreme Support Catheters are specialized catheters designed to provide enhanced support during vascular interventions. They help in navigating through complex vascular anatomy and facilitate the delivery of other interventional devices, such as stents or balloons. These catheters are known for their flexibility and strength, making them suitable for challenging procedures.
Clinical Applications
These catheters are commonly used in procedures involving venous stents, especially in cases where additional support is needed to navigate tortuous vessels. Interventional cardiologists and radiologists often use them in hospital settings, particularly in catheterization labs. They are suitable for patients requiring complex vascular interventions, including those with peripheral artery disease.
Indications for Use
The FDA indications for these catheters involve their use in providing support during vascular procedures. They are intended for patients undergoing interventions that require the placement of stents or other devices in the venous system.
Practical Considerations
The catheters come in various sizes to accommodate different vessel diameters and are compatible with standard guidewires and other interventional tools. Clinicians should be aware of the catheter's length and diameter to ensure proper fit and function during procedures.
Frequently Asked Questions
What is Spectranetics Quick Cross Extreme Support Catheters used for?
They are used to provide support and facilitate the delivery of interventional devices during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use these catheters in vascular interventions.
What are the FDA-cleared indications?
The catheters are indicated for use in providing support during vascular procedures, particularly for the placement of stents 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.