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medtronic 6210 permanent lead introduc
Medtronic Vascular
Summary: The Medtronic 6210 Permanent Lead Introducer is a medical device used for the placement of leads in procedures such as embolization. It is primarily utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K842780 ↗
Decision Date
August 3, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medtronic 6210 Permanent Lead Introducer was cleared through the FDA 510(k) pathway on August 3, 1984. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Medtronic 6210 Permanent Lead Introducer is a specialized tool designed to facilitate the insertion of leads into the vascular system. It is typically used in procedures that require precise placement of leads, such as in cardiac or neurovascular interventions. The device aids in navigating the vascular anatomy, ensuring accurate positioning of the lead for optimal therapeutic outcomes.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for procedures involving embolization coils. It is suitable for adult patients requiring vascular access for lead placement. The introducer is utilized in both inpatient and outpatient settings, often in catheterization labs or specialized procedure rooms.
Indications for Use
The Medtronic 6210 Permanent Lead Introducer is indicated for use in patients who require the placement of leads within the vascular system. It is particularly useful in conditions where precise lead placement is critical, such as in cardiac rhythm management or neurovascular interventions.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard lead systems and requires careful handling to prevent vascular injury. Clinicians should be trained in its use to maximize procedural success and minimize complications.
Frequently Asked Questions
What is the Medtronic 6210 Permanent Lead Introducer used for?
It is used for the placement of leads in vascular procedures, such as those involving embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for the placement of leads in the vascular system, particularly in procedures requiring precise lead positioning.
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.