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vipercath xc peripheral exchange catheter
Cardiovascular Systems
Summary: The Vipercath XC Peripheral Exchange Catheter is a medical device used in vascular procedures to facilitate the exchange of guidewires and other devices. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K211251 ↗
Decision Date
May 26, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vipercath XC Peripheral Exchange Catheter, manufactured by Cardiovascular Systems, received FDA 510k clearance (K211251) on May 26, 2021. It is classified as a Class 2 medical device under product code DQY.
What It Is
The Vipercath XC Peripheral Exchange Catheter is a specialized catheter designed for use in peripheral vascular procedures. It enables the exchange of guidewires and other interventional devices within the vascular system. The catheter's design allows for precise navigation and placement, which is crucial in complex vascular interventions.
Clinical Applications
This catheter is commonly used in procedures involving the placement of venous stents, particularly in the treatment of peripheral artery disease. Interventional radiologists and vascular surgeons use it in hospital settings, often in catheterization labs, to manage vascular obstructions or to facilitate other interventions. It is suitable for adult patients with peripheral vascular conditions.
Indications for Use
The Vipercath XC is indicated for use in patients requiring vascular interventions, particularly those needing the placement of venous stents. It is designed to assist in the exchange of guidewires and other devices during these procedures.
Practical Considerations
The Vipercath XC is available in various sizes to accommodate different vascular anatomies. It is compatible with standard guidewires and other interventional devices. Clinicians should be familiar with catheterization techniques and ensure proper sizing for effective use.
Frequently Asked Questions
What is Vipercath XC Peripheral Exchange Catheter used for?
It is used to facilitate the exchange of guidewires and other interventional devices during vascular procedures, particularly in the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in vascular interventions requiring the exchange of guidewires and devices, especially in procedures involving venous stents.
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.