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6f envoy guiding catheter
Cordis
Summary: The 6f Envoy Guiding Catheter by Cordis is used in neurovascular procedures. It is FDA 510k cleared and supported by 8 studies highlighting its efficacy and safety in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K982770 ↗
Decision Date
August 18, 1998
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 6f Envoy Guiding Catheter was cleared via the FDA 510k pathway on August 18, 1998. Manufactured by Cordis, it is classified as a Class 2 device under product code DQY.
What It Is
The 6f Envoy Guiding Catheter is a medical device designed to provide support and navigability for endovascular procedures, particularly in neurovascular interventions. It is intended for use in guiding other devices to the target site within the vasculature.
Clinical Applications
Commonly used in neurointerventional procedures such as coil embolization of cerebral aneurysms and middle meningeal artery embolization. It is also utilized in transradial and transfemoral approaches for various vascular interventions.
Evidence Summary
The literature includes 8 studies ranging from 2021 to 2024, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies evaluate the catheter's efficacy and safety in different clinical scenarios.
Reported Outcomes
Published studies report successful procedural outcomes with the 6f Envoy Guiding Catheter, including high procedural success rates and effective support for working devices. One study noted successful completion of procedures with no adverse effects, allowing same-day patient discharge.
Safety Profile
Reported complications include low access site complication rates and no life-threatening complications. The device is generally considered safe with a favorable safety profile in the studies reviewed.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to explore the device's performance in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for 6f Envoy Guiding Catheter?
The 6f Envoy Guiding Catheter is indicated for use in neurovascular procedures, including coil embolization of cerebral aneurysms and middle meningeal artery embolization.
What outcomes have been reported in clinical studies?
Clinical studies have reported high procedural success rates and effective support for working devices, with some studies noting successful completion of procedures with no adverse effects.
What complications have been reported?
Reported complications include low access site complication rates and no life-threatening complications, indicating a favorable safety profile.
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.