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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 510K
Number K982883 ↗
Decision Date September 4, 1998
Product Code DQY
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.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology and radiology procedures. It is particularly useful in settings where precise delivery of stents or other devices is required, such as in the treatment of venous obstructions or during complex vascular interventions. The device is suitable for adult patients undergoing such procedures.
Indications for Use
The FDA-cleared indications for this device include its use in guiding and supporting the placement of stents and other devices in the venous system. It is intended for patients requiring vascular interventions to address conditions such as venous stenosis or occlusions.
Practical Considerations
The Medtronic Zuma Guiding Catheter is available in 7F and 8F sizes, allowing for compatibility with a range of interventional devices. Clinicians should ensure proper selection of catheter size based on the specific procedure and patient anatomy. Familiarity with catheter handling techniques is essential for optimal performance.
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.