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zuma guide catheters
Medtronic Vascular
Summary: Zuma guide catheters, manufactured by Medtronic Vascular, are used in vascular interventions. FDA cleared via 510k pathway. Studies highlight their use in coronary and renal procedures.
FDA Clearance Information
Pathway
510K
Number
K000677 ↗
Decision Date
March 29, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Zuma guide catheters were cleared by the FDA through the 510k pathway on March 29, 2000. Manufactured by Medtronic Vascular, they are classified as Class 2 devices.
What It Is
Zuma guide catheters are medical devices used to facilitate the delivery of stents and other therapeutic devices in vascular interventions. They are designed for use in venous stenting procedures, providing support and guidance during catheterization.
Clinical Applications
Commonly used in coronary and renal interventions, Zuma guide catheters assist in the delivery of stents and other devices through transradial or transfemoral approaches. They are particularly useful in cases requiring precise navigation through tortuous or calcified vessels.
Evidence Summary
The available literature includes three studies published between 2001 and 2002. These studies encompass various methodologies, including feasibility pilot studies and case series, focusing on the use of guide catheters in coronary and renal procedures.
Reported Outcomes
Published studies report successful stent delivery and procedural completion using Zuma guide catheters in coronary and renal interventions. The studies highlight the catheters' effectiveness in navigating challenging vascular anatomies and achieving desired clinical outcomes.
Safety Profile
Reported complications include challenges in catheter navigation in severely tortuous vessels. However, the studies do not provide detailed safety data or adverse event rates, indicating a need for further research in this area.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of comprehensive safety data. Further research is needed to evaluate long-term outcomes and potential complications associated with the use of Zuma guide catheters.
Frequently Asked Questions
What are the clinical indications for Zuma guide catheters?
Zuma guide catheters are indicated for use in vascular interventions, particularly in coronary and renal stenting procedures.
What outcomes have been reported in clinical studies?
Studies report successful stent delivery and procedural completion in coronary and renal interventions using Zuma guide catheters.
What complications have been reported?
Reported complications include challenges in navigating tortuous vessels, though detailed safety data is limited.
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.