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Nexgen Peripheral Guide Catheter
Nexgen Medical Systems
Summary: The Nexgen Peripheral Guide Catheter is a medical device used in vascular procedures to assist in the placement of stents. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102979 ↗
Decision Date ?
January 18, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Nexgen Peripheral Guide Catheter was cleared through the FDA 510k pathway on January 18, 2011. It is manufactured by Nexgen Medical Systems and classified as a Class 2 device.
What It Is
The Nexgen Peripheral Guide Catheter is a specialized catheter designed to facilitate the placement of venous stents. It provides support and guidance for other instruments during vascular interventions. This device is crucial in ensuring precise delivery and positioning of stents in peripheral veins, enhancing procedural success and patient outcomes.
FDA-Cleared Indications
- Use in percutaneous vascular procedures as a catheter for guiding or supporting other interventional devices.
- Use in procedures involving the placement of vascular stents, when consistent with the device-specific labeling and compatible equipment.
- Use in adult patients when selected by a qualified clinician for an appropriate peripheral vascular intervention.
Clinical Applications
- Providing catheter support during peripheral vascular interventions.
- Creating a pathway for delivery or positioning of compatible endovascular instruments.
- Assisting procedures involving peripheral venous stent placement.
- Supporting treatment of selected venous obstructions when a compatible stenting procedure is clinically indicated.
Practical Considerations
- Confirm the catheter's labeled diameter, length, working-channel dimensions, and compatibility with the planned guidewire, stent, sheath, and other instruments before use.
- Use fluoroscopic or other appropriate imaging guidance and follow institutional protocols for vascular access, advancement, and device removal.
- The supplied FDA record does not state whether this specific catheter is MR Safe, MR Conditional, or MR Unsafe; review the current product labeling before MRI exposure.
- Potential contraindications and warnings should be taken from the current manufacturer instructions for use, including factors related to vascular access, bleeding, infection, vessel injury, and device incompatibility.
- This is a single-procedure catheter unless the manufacturer labeling specifically permits another use; do not reuse or resterilize it when the labeling prohibits reuse.
Procedures that use this device
Frequently Asked Questions
What is the Nexgen Peripheral Guide Catheter used for?
It is used to assist in the placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents, particularly for patients with venous obstructions.
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.