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6f sherpa nx balanced guide catheter 7f sherpa nx balanced guide catheter
Medtronic Vascular
Summary: The Sherpa NX Balanced Guide Catheter is a medical device used in vascular procedures, primarily by interventional cardiologists and radiologists. It assists in the placement of other devices within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K232190 ↗
Decision Date
August 22, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sherpa NX Balanced Guide Catheter, manufactured by Medtronic Vascular, was cleared through the FDA 510(k) pathway on August 22, 2023. It is classified as a Class 2 device under product code DQY.
What It Is
The Sherpa NX Balanced Guide Catheter is a flexible tube designed to provide support and guidance for other devices during vascular interventions. It is typically inserted into the vascular system to facilitate the delivery of stents, balloons, or other therapeutic devices. Its balanced design aims to enhance maneuverability and stability within the vessel.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings for procedures involving the placement of venous stents. It is particularly useful in complex vascular interventions where precise device placement is critical. The device is suitable for use in hospitals and specialized clinics, often involving patients with vascular diseases or blockages.
Indications for Use
The FDA-cleared indications for the Sherpa NX Balanced Guide Catheter involve its use in procedures requiring the placement of venous stents. It is designed for patients with vascular conditions that necessitate such interventions.
Practical Considerations
The Sherpa NX Balanced Guide Catheter is available in different sizes, typically 6F and 7F, to accommodate various patient anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should be aware of the specific technique required for its insertion and navigation within the vascular system.
Frequently Asked Questions
What is the Sherpa NX Balanced Guide Catheter used for?
It is used to provide support and guidance for the placement of other devices, such as stents, within the vascular system.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents, particularly in patients with vascular conditions.
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.