đź“‹ FDA Reference
Medtronic Model 5401b Test Cable
Medtronic Vascular
Summary: The Medtronic Model 5401b Test Cable is a medical device used primarily for testing purposes in interventional procedures. It is typically utilized by healthcare professionals in vascular and interventional radiology settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896632 ↗
Decision Date ?
December 13, 1989
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic Model 5401b Test Cable was cleared through the FDA 510(k) pathway on December 13, 1989. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DTC.
What It Is
The Medtronic Model 5401b Test Cable is a specialized cable used in the testing and calibration of medical devices, particularly those involved in vascular interventions. It ensures that devices such as IVC filters are functioning correctly before and during procedures. This cable plays a crucial role in maintaining the accuracy and safety of interventional devices.
FDA-Cleared Indications
- Use as a test cable with compatible medical equipment according to the manufacturer’s labeling.
- Use to test or verify the operation of compatible devices or systems used in vascular procedures.
Clinical Applications
- Testing compatible vascular-intervention equipment before or during a procedure.
- Connecting compatible equipment to a testing or calibration system.
- Supporting equipment checks in interventional radiology or vascular surgery when specified by the manufacturer.
Practical Considerations
- Confirm compatibility with the specific device, generator, testing system, and connector before use; compatibility cannot be inferred from the product code alone.
- Follow the manufacturer’s instructions for connection, testing, cleaning, storage, and inspection. Do not use a cable with visible damage or compromised connectors.
- The available FDA record does not provide cable dimensions, connector specifications, or a list of compatible devices; consult the original labeling or the manufacturer.
- MRI safety is not established in the available record. Do not bring the cable into an MRI environment unless its MR status and conditions of use are specifically documented.
- This is an accessory for equipment testing, not an implant or a therapeutic device. It should not be used as a substitute for a clinically indicated vascular procedure or treatment.
Procedures that use this device
Frequently Asked Questions
What is the Medtronic Model 5401b Test Cable used for?
It is used for testing and calibrating medical devices, particularly in vascular interventions, to ensure they function correctly.
What specialties typically use this device?
Interventional radiology and vascular surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in ensuring the proper function of devices used in IVC filter retrieval procedures.
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.