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Medtronic 7f and 8f Zuma Guiding Catheter
Medtronics Interventional Vascular
Summary: The Medtronic 7F and 8F Zuma Guiding Catheter is a medical device used primarily by interventional cardiologists for guiding stents and other devices into the venous system. It is designed for use in various vascular procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K982883 ↗
Decision Date ?
September 4, 1998
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic 7F and 8F Zuma Guiding Catheter was cleared via the FDA 510(k) pathway on September 4, 1998. Manufactured by Medtronics Interventional Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Medtronic 7F and 8F Zuma Guiding Catheter is a specialized catheter used in interventional vascular procedures. It is designed to provide support and guidance for the delivery of stents and other therapeutic devices into the venous system. The catheter's design allows for precise navigation through the vascular anatomy, ensuring accurate placement of devices.
FDA-Cleared Indications
- Used percutaneously to guide and support the placement of other interventional devices during vascular procedures.
- Intended for use with compatible devices when access, positioning, and support are required during catheter-based intervention.
Clinical Applications
- Guiding delivery of compatible stents during catheter-based vascular intervention.
- Providing support for the placement of other compatible therapeutic devices.
- Establishing a catheter pathway during adult percutaneous vascular procedures when the selected catheter size and configuration are appropriate.
Practical Considerations
- Available in 7F and 8F sizes; the appropriate size depends on the planned procedure, access vessel, anatomy, and compatibility requirements of the devices being delivered.
- Use requires fluoroscopic or other appropriate imaging guidance and standard catheterization technique.
- The supplied FDA summary does not specify MRI safety labeling. MRI conditions should be confirmed in the current manufacturer instructions for use before scanning a patient with the catheter in place.
- Potential complications are typical of percutaneous catheter procedures and may include bleeding or hematoma, vascular injury, thrombosis, embolization, infection, contrast reaction, and vessel perforation.
- Do not use when the catheter, intended device, access route, or patient condition is incompatible with the manufacturer’s instructions. Clinicians should review the current labeling for contraindications, warnings, and device compatibility.
Procedures that use this device
Frequently Asked Questions
What is the Medtronic 7F and 8F Zuma Guiding Catheter used for?
It is used for guiding and supporting the placement of stents and other devices in the venous system during vascular interventions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in guiding and supporting the placement of stents and other devices in the venous system for patients requiring vascular interventions.
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.