đź“‹ FDA Reference
Envoy and Vista Brite Tip
Summary: The Envoy and Vista Brite Tip are venous stents used primarily in interventional radiology and cardiology to support vessel patency. They are utilized by clinicians to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K982632 ↗
Decision Date ?
August 18, 1998
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Envoy and Vista Brite Tip were cleared via the FDA 510(k) pathway on August 18, 1998. Manufactured by Cordis, these devices are classified as Class II under product code DQY.
What It Is
The Envoy and Vista Brite Tip are specialized venous stents designed to maintain open blood vessels in the venous system. They are constructed to provide structural support to veins, preventing collapse and ensuring proper blood flow. These stents are typically delivered via catheter and expanded in place to fit the vessel's dimensions.
FDA-Cleared Indications
- Percutaneous catheter use as described under FDA product code DQY (Catheter, Percutaneous; 21 CFR 870.1250).
- The supplied FDA record lists a summary rather than specific disease, vessel, or treatment indications.
Clinical Applications
- Use as a percutaneous catheter during an image-guided endovascular procedure.
- Accessing or treating a vessel when the device size and configuration are appropriate for the planned procedure.
- Use by trained clinicians according to the device labeling, instructions for use, and patient-specific anatomy.
Practical Considerations
- Confirm the exact device model, size, delivery-system compatibility, and current instructions for use before the procedure.
- The supplied FDA record does not provide enough information to determine MRI safety; verify MR labeling for the specific device and configuration.
- Assess vascular anatomy, access-site suitability, anticoagulation status, infection risk, and other procedure-specific contraindications.
- Do not infer venous-stent indications, vessel locations, or long-term patency claims without the original labeling or manufacturer documentation.
- Use fluoroscopic or other appropriate imaging guidance and follow institutional protocols for catheter handling and deployment.
Procedures that use this device
Frequently Asked Questions
What is Envoy and Vista Brite Tip used for?
They are used to maintain open blood vessels in the venous system, particularly in cases of venous obstruction.
What specialties typically use this device?
Interventional radiology and cardiology specialists commonly use these stents.
What are the FDA-cleared indications?
They are indicated for maintaining vessel patency in patients with venous blockages.
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.