đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used as a lead connector modification in systems associated with IVC filters.
- Intended to provide or maintain a secure connection between compatible components of the lead system.
Clinical Applications
- Connection of compatible lead components during an IVC filter procedure.
- Use with an IVC filter system when a low-profile connector modification is specified by the device labeling.
- Use by trained clinicians in an operating room or interventional suite according to the applicable device instructions.
Practical Considerations
- Confirm compatibility with the specific IVC filter, lead, and accessory components before use; the available record does not list compatible models or connector dimensions.
- Follow the manufacturer’s instructions for connection, handling, and inspection. An insecure or incompatible connection could affect system function.
- The available FDA record does not establish MRI safety. MRI conditions should be verified from the complete labeling for the connector and the implanted or connected system.
- Do not use if the component is damaged, contaminated, or incompatible with the intended system.
- The record identifies a 510(k) decision in 1980 and a Class III classification; current labeling, availability, and regulatory status should be confirmed before clinical use.
Procedures that use this device
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.