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low profile lead connector modification 4002
Medtronic Vascular
Summary: The Low Profile Lead Connector Modification 4002 is a medical device used in conjunction with IVC filters to ensure secure lead connections. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K801284 ↗
Decision Date
December 1, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Low Profile Lead Connector Modification 4002 was cleared through the FDA 510(k) pathway on December 1, 1980. Manufactured by Medtronic Vascular, it is classified as a Class III device.
What It Is
The Low Profile Lead Connector Modification 4002 is designed to facilitate secure connections in medical devices, particularly those involving IVC filters. Its low-profile design helps minimize interference with surrounding anatomical structures. This device is crucial in maintaining the integrity and functionality of the lead systems used in vascular interventions.
Clinical Applications
This device is commonly used in procedures involving inferior vena cava (IVC) filters, which are often deployed to prevent pulmonary embolism in patients with deep vein thrombosis. Interventional radiologists and vascular surgeons use it in hospital settings, particularly in operating rooms and interventional suites, to ensure reliable lead connections during and after the placement of IVC filters.
Indications for Use
The FDA indications for this device involve its use in securing lead connections in systems that include IVC filters. It is intended for patients who require such filters due to conditions like deep vein thrombosis or risk of pulmonary embolism.
Practical Considerations
When using the Low Profile Lead Connector Modification 4002, clinicians should be aware of its compatibility with various IVC filter systems. Its design allows for easy integration, but proper technique is essential to ensure secure connections. The device's sizing and compatibility with existing systems should be verified before use.
Frequently Asked Questions
What is Low Profile Lead Connector Modification 4002 used for?
It is used to secure lead connections in medical devices, particularly those involving IVC filters.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for securing lead connections in systems that include IVC filters, often for patients at risk of pulmonary embolism.
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.