đź“‹ FDA Reference
Modification to Envoy and Vista Brite Tip
Product: Supertorque — all models and sizes
Summary: The modification to Envoy and Vista Brite Tip by Cordis is a Class 2 medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021593 ↗
Decision Date ?
June 13, 2002
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on June 13, 2002. It is manufactured by Cordis and classified as a Class 2 device under product code DQY.
What It Is
This device is a modification of existing catheter systems, designed to facilitate the placement of stents in venous structures. It features enhancements that improve navigation through the vascular system and provide better support during stent deployment. The device is part of the Envoy and Vista Brite Tip family, known for their flexibility and radiopacity, which aid in precise placement.
FDA-Cleared Indications
- For percutaneous catheter-based vascular procedures requiring catheter access and navigation.
- For use with compatible interventional devices during procedures involving vascular structures.
- The available FDA record does not provide a more specific indication for venous stenting or a particular disease.
Clinical Applications
- Catheter access and navigation during image-guided vascular intervention.
- Support of compatible devices during catheter-based treatment of venous disease when consistent with the cleared configuration and labeling.
- Use during venous stenting procedures involving iliac or central venous segments when the catheter is labeled and compatible for that application.
Practical Considerations
- Confirm the exact catheter model, length, diameter, tip configuration and other specifications in the current manufacturer labeling before use.
- Use only with compatible guidewires, stents and delivery systems; verify inner diameter, working length and device compatibility.
- The catheter is navigated under fluoroscopy or other appropriate imaging guidance by trained clinicians.
- MRI safety depends on the exact device configuration and labeling. Do not assume that the catheter is MR safe or MR conditional without checking the current instructions for use.
- Potential complications of catheter-based vascular procedures include bleeding, hematoma, vessel injury, thrombosis, infection, embolization and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What is modification to envoy and vista brite tip used for?
It is used for placing stents in venous structures to treat conditions like venous obstruction or insufficiency.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is cleared for use in venous stenting procedures, particularly for treating venous blockages or insufficiencies.
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.