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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
510K
Number
K102979 ↗
Decision Date
January 18, 2011
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology for procedures involving the placement of venous stents. It is particularly useful in treating patients with venous obstructions or insufficiencies. The device is typically utilized in hospital settings, catering to adult patients who require vascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the placement of venous stents. It is suitable for patients with conditions such as venous obstructions or other vascular issues requiring stent placement.
Practical Considerations
Clinicians should be aware of the catheter's compatibility with various stent sizes and guidewires. Proper technique is essential for optimal performance, and familiarity with vascular anatomy is crucial for successful use. The device is available in multiple sizes to accommodate different patient anatomies.
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.